11 Design Control Jobs

Key Deliverables: Provide quality oversight across design, validation, and lifecycle of combination products Support regulatory submissions, audits, and RTQ responses Ensure compliance with global standards including ISO 13485 and 21 CFR Lead quality process improvements for device, labeling, and packaging Role Responsibilities: Act as single point of quality contact for final product activities Review risk management, HFE documentation, and design controls Train teams on quality and regulatory requirements for combination products Manage complaint investigations and site transfer quality activities

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.. You will be responsible for developing creative solutions to challenging issues associated with the design, development, and sustaining engineering for our new and existing Disposable subsystems of dialysis product portfolio. The successful candidate will possess solid “hands-on” technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.. Leads the evaluation and development of mechanical and Fluid control systems by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.. Leads team in defining project strategies, developing goals, and ensures project scope is defined and controlled. Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies. Ensures successful integration of mechanical design entities with interface Systems and consumable components.. Contributes to troubleshooting and problem solving efforts related to mechanical and regulatory aspects of the design and interfaces with other design constituents.. Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards within area of responsibility/expertise. Defines the required tasks, test plans, deliverables, and technical direction. Constructs detailed, accurate project schedules interfacing with product development, quality, regulatory, manufacturing, and other cross functional teams.. Contributes to development and documentation of mechanical systems architectures.. Able to design Plastic components with expertise in manufacturing of plastic components. Able to effectively transition products to manufacturing and ensure robust products and manufacturing processes. Improves mechanical designs that are optimized for production, reliability, regulatory compliance and cost.. Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing. Ensures Systems that are optimized for production, reliability, regulatory compliance, and cost.. Performs in-depth mechanical engineering analysis/FEA/CFD and calculations.. Responsible for integration of deliverables from sub-system design teams and external partners.. Resolves competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.. Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s).. Qualifications. A graduate or a post graduate in Mechanical or related engineering and 14+ years related experience. Prior experience in Renal device/Medical domain is a plus.. A demonstrated track record in Plastic component design and development, preferably medical devices or other highly regulated product domain such as aircraft/automotive/defense industries.. A proven track record of effectiveness in a fast paced environment.. Proven ability to create results within budget, timeline, and product/project deliverables.. Reasonable Accommodation. Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link. Recruitment Fraud Notice. Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.. Show more Show less

Role & responsibilities: Responsible for monitoring and management of projects in assigned division / sub-division / ULBs. Day-to-day supervision of construction works including design control, quality assurance and quality control, schedule, and budget control. Assessing adequacy of contractors plant, equipment, materials, labour to carry out works as the per approved work program. Performance monitoring of works contractors. Report on tests. Review of contractors submittals such as work plans, work schedules, method statements, progress reports, designs, and drawings, etc. Preparation of daily, weekly, monthly progress reports. Maintaining photographic records of each assigned project. Responsible for monitoring and management of projects in assigned division / sub-division / ULBs. Day-to-day supervision of construction works including design control, quality assurance and quality control, schedule, and budget control. Assessing adequacy of contractors plant, equipment, materials, labour to carry out works as the per approved work program. Performance monitoring of works contractors. Report on tests. Review of contractors submittals such as work plans, work schedules, method statements, progress reports, designs, and drawings, etc. Preparation of daily, weekly, monthly progress reports. Maintaining photographic records of each assigned project. Minimum Qualification & Work Experience Required: Bachelor’s in Civil Engineering is required. Atleast 12 years’ of overall experience with 5 years’ of relevant construction supervision experience of water supply and used water infrastructure projects.

What this job involves You will be responsible to ensure all necessary utilities are being given to the occupants/tenants. You will be responsible for all drawing submissions and approvals to be maintained for fitout work. The contractor will coordinate with you for all minor execution issues. Building maintenance and upkeep will be one of your KRA. Your key deliverables will be: Maintain records of all building drawing. Make sure all instruction guidelines are being followed as per the fitout manual. Provide necessary permits (Night work, hot work, height work). Coordinate for all necessary security arrangements for execution of fitout activities. Monitor and control work in progress as per approved plan by the client. Ensure completion of Snagging and De-snagging work of flats Common area. Ensure all safety requirements are being followed at the site. Advise contractor on minor execution issues. Ensure that all work meets client design control specifications. Daily visit to ongoing fit-out work for checking of civil work layout. Working closely with management to help improve and maintain the building in clean and maintenance free condition. You will be meeting with all clients who are going to start the fit-out work to resolve queries of clients regarding the working procedures, instruction and for material handling as per approved drawings and other documents related to fit out work and operation activities. Maintain a fitout tracker. Providing the clients with suitable energy conservation plans. Coordinate and maintain the as-built drawing and transition document library. Work closely with the regional RO HO SME/ Training teams and ensure closures of all required reports. Facilitate the services under the Slogan No Safety No Work. Site dynamics: 1. Work Schedule: 2. Site team: e.g.: Property Manager +2 3. Other details if any. Reporting: You will be working with our operations team and reporting to the Property Manager. Sound like you Here is what were looking for: Being Analytical and Meticulous Your role will involve coordination with various teams/ vendors. You will be paying attention to detail and have excellent problem-solving skills. You will be using logic to trouble-shoot problems; and assign and monitor maintenance projects. You should have a good knowledge of the working procedures for fitout. Qualifications You will have a Degree Diploma or relevant educational background in Civil Engineering with minimum 1-2 years of work experience. On-site Mumbai, MH

Verification and Validation R&D Primary responsibilities: Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs. Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management. Generate or apply statistical methods with appropriate risk-based justification. Hands-on experience in Design History File compilation / Technical file documentation. Support internal and external inspections/ regulatory audits. Promote continuous improvement in design control activities and use of quality tools with design team. In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Secondary responsibilities (Wherever applicable): Experience interacting with regulatory agencies and notified bodies Experience with process improvements, process qualification and validation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.

Your key responsibilities The Senior will support teams of FAAS professionals during engagements covering a broad spectrum of Process and Control areas. The Senior will be responsible for the following tasks: Responsible for executing client related engagements in the areas of governance, risk & compliance (GRC), process reviews, standard operating procedures, enterprise risk management, SOX, Internal Control over Financial Reporting (ICFR). Supporting SOX engagement, Process and Control; or should be an expert in driving Financial Statement Close Process, Procure to Pay and Order to Cash, Inventory, Fixed Assets, PPE & Intangible assets processes (along with experience in Risk management) Supporting projects related to Process Improvement and Implementation, drafting risk and control matrix, process placemats and documenting SOPs. Supporting engagement planning, budgeting, execution and management Preparing products/deliverables meet contract/ work plan specifications and deadlines Supporting the development of tools and methodologies for project delivery Participating in meetings and interviews with client personnel Developing creative, yet practical, solutions to help our clients achieve their Process and Control objectives Developing client deliverables and engagement documentation Developing, tracking and supporting actual engagement economics versus the budget Supporting the development and management of the relationships with external and internal clients Supporting development of new service offerings and go-to-market strategies Supporting other ad-hoc internal initiatives geared towards improving our groups efficiency, effectiveness and integration with other service lines To qualify for the role, you must have Chartered Accountant (CA), CPA (US) or ACCA (UK) with 3+ years of experience with a large Global Corporate Process, Risk and Control department and/or similar experience MBA degree is a plus Experience with the following Process and Control areas: Governance, controls and regulation Governance, Risk & Compliance Process and Control Process reviews Standard Operating Procedures Enterprise Risk Management Revenue Assurance SOX Internal Control over Financial Reporting (ICFR) Design and Implementation testing

Job Description Job title: Quality Engineer, Products and Systems Your role: Be part of Project team and participate in defining product design input, requirements, V&V, output and design transfer requirements and plans. Ensure product quality, compliance and state of art throughout the product lifecycle. Reaffirm that design input are transferred to product design and verified to confirm that design output meet the design input. In collaboration with multi-disciplinary team, lead the design for reliability to create a reliability plan and include the reliability requirements in product design. Ensure that reliability requirements are met through test, verification and validations, as applicable. A distinguished champion on patient safety and quality with expertise on quality and compliance principles like IEC60601, IEC 62304, IEC62366, 21CFR806. You will be acting as subject matter expert to provide guidance on product design quality, safety, reliability, serviceability, maintainability, manufacturability and other aspect in collaboration with business and technical SMEs. Well conversant with QMS requirements in accordance with ISO13485:2016 and ISO14971. Expert in medical device risk management principles including risk evaluation, assessment, risk determination, mitigation and risk benefit analysis. You will be acting as facilitator for risk management activities in accordance with ISO14971 and other applicable regulatory requirements. You're the right fit if: (4 x bullets max) Experience: 12 to 20 Years, minimum 10 years in Medical device industry. Bachelor's in engineering or quality management, with 12 to 20 Years, minimum 10 years in Medical device industry. Proven knowledge of the FDA regulations for Design Controls for medical devices is a must and the combination with (extensive) experience with regulatory inspections has a very strong preference. Product Quality Engineering and Design Control experience is a requirement. Certification in Software Quality Engineering (CSQE) from ASQ or other bodies is desirable In-depth knowledge and a proven track record in implementing and applying concepts in the fields of designing in quality, reliability and problem-solving techniques have a strong preference. Leadership experience and good change management and influencing skills (required) You are Customer, Patient Safety and Quality focused. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR. Advanced level knowledge of IEC62304, IEC62366 and ISO14971 has a strong preference. Excellent communication skills, able to clearly and concisely summarize complex technical problems You combine analytical and conceptual thinking, physical insight, system view, flexibility and a Handson mentality to deliver sustainable results and creative solutions. You are a motivated self-propelling person, with determination to succeed and the ability to manage change. Excellent organizational skills to lead and track deliverables Strong influencing skills power of persuasion, perseverance, getting things done mentality. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. u2022 Learn more about . u2022 Discover . u2022 Learn more about . If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Summary The Lead System Integrator (LSI) team is a part of the R&D organization that supports the Kidney Care business segment Within the team, we provide R&D focused project management support for all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems, Vantive is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites and with other functional representatives Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities, The Kidney Care R&D Drug Products and Sciences (DPS) organization is responsible for Kidney Care drug products (dialysis solutions, concentrates, etc) and related sciences (Sterility Assurance, Analytical Chemistry, materials compliance, Extractables & Leachables, Toxicology) As a member of the Drug Products and Sciences organization, the Lead System Integrator co-ordinates/leads DPS R&D activities within a Project or Program with her/his Project Management and Technical Leadership skills This role may be responsible for supporting multiple projects, Essential Duties and Responsibilities This section contains a list of five to eight primary responsibilities of the work The incumbent will perform other duties as assigned, Lead research and development (R&D) project management work for drug products, medical devices, and other regulated healthcare products Owner of R&D program schedule creation, tracking, and execution Integrate inputs from all DPS competencies/subject matter experts into a harmonized project proposal, project schedule, technical risk assessment, and other project plans, Participates as a member of cross functional teams and/or integrates cross functional inputs into project deliverables Accountable for project execution and proactive risk management Effectively tracks project status, risks, budget, and external spend, Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards Prepares project reports, analyses and delivers presentations to R&D leadership on a regular basis Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the project Establish project communication channels and archives e-g , Teams group, Status meetings, Escalation matrix, etc Facilitate/organize DPS R&D project design reviews and change control meetings Facilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (e-g , external labs, translation agencies, etc ) Across multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunities Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily List knowledge, skills, and/or abilities required, Experience in project management principles and methodologies Strong interpersonal and communication skills in written and verbal form Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc ), Ability to provide technical leadership and coordination for medical product projects with substantial complexity and scope, Ability to decompose complex problems into actionable plans and track them to closure Understanding of design requirements for development, validation, and verification of medical products Education and/or Experience Include the education and/or experience that is necessary to perform the job satisfactorily, Bachelors degree in Engineering, Science or related field 10+ years of relevant R&D, Project management (or similar) experience preferred Experience in pharmaceuticals or medical product industry preferred Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Looking for a challenging role? If you want to make a difference - make it with us Can we energize society and fight climate change at the same time? At Siemens Energy, we can. Our technology is key, but our people make the difference. Brilliant minds innovate. They connect, create, and keep us on track towards changing the world"™s energy systems. Their spirit fuels our mission. Our culture is defined by caring, agile, respectful, and accountable individuals. We value excellence of any kind. Sounds like you? We make real what matters. This is your role As an Engineering specialist, design control philosophy and wiring schematics for EHV and HV AIS circuit breakers. Responsible for preparing engineering documents, discussions with customers regarding open points, and arranging drawing approvals by conducting meetings/customer visits to customers like PGCIL, NTPC, and other major utilities. Take handover from the Sales/Order Acquisition team and understand all documents and specifications to provide engineering documents in line with agreed technical parameters. Checking and maintaining/configuring SAP BOM for all Circuit Breaker and spare orders. Spares and internal order booking/customer complaints booking in SAP and maintaining bill of material. Understanding non-standard requirements and circulating correct information about the drawings through manufacturing instructions. Engage with internal stakeholders to clear all engineering documents, Bills of materials, SAP codes, etc. What you need to make real what matters You should be a graduate/postgraduate in Electrical engineering, have sufficient product knowledge, and 3 to 5 years of industry experience. You should have Strong strategic planning, negotiation, customer intimacy, organizational skills, proactiveness, strong decision-making, ownership mindset, and soft skills. Excellent analytical and problem-solving skills with the ability to manage multiple disciplines simultaneously. Knowledge of Auto CAD, E-Plan, CAD Worx E&I, and SAP. You"™ve good knowledge of High Voltage Circuit breakers of Air Insulated Substations. We"™ve got quite a lot to offer. How about you? This role is based in " Aurangabad ". You"™ll also get to visit other locations in India and beyond, so you"™ll need to go where this journey takes you. In return, you"™ll get the chance to work with teams impacting entire cities, countries and the shape of things to come. We"™re Siemens. A collection of over 379,000 minds building the future, one day at a time in over 200 countries. We're dedicated to equality, and we welcome applications that reflect the diversity of the communities we work in. All employment decisions at Siemens are based on qualifications, merit, and business needs. Bring your curiosity and imagination and help us shape tomorrow.

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master’s degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor’s degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master’s degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Security Architect Selected candidate to support our client, APAC based Investment bank, in Security Architect profile. Our client is seeking a highly skilled and proactive Security Architect to play a crucial role in their team ensuring the security and compliance of project / application implementation, with a particular focus on Cloud services and technologies for all business units. KEY RESPONSIBILITIES Conduct security-by-design reviews on new programs, initiatives, projects, Cloud services and technologies regionally (in-house development, Commercial Off-The-Shelf, SaaS), ensuring sufficient documentation for compliance / audit. Collaborate with Group and Regional information security teams, as well as business stakeholders, to ensure project implementation aligns with security controls in accordance with policies, standards, guidelines, and regulations. Take part in the security architecture blueprint and design review process for the Cloud hosted solutions. Ensure critical vulnerabilities are tracked and remediated prior to application go-live. Analyse, review, and approve non-standard software/technology implementations regionally. Perform ad-hoc and periodic reviews of Proxy/Network/Firewall requests, designs, and configurations in client network. Provides advisory and consultation to business units, business owners, and project teams for any Cloud Security related matters. Create a culture of security-by-design awareness by conducting related training for LBUs and other relevant stakeholders. Create, maintain, and update relevant security policies, standards, and operating procedures for client. Support the team leader with any assigned security operation tasks related to endpoint security, network security, data protection, DLP, VAPT, security alerts, and incidents. EXPERIENCE / QUALIFICATIONS Recognized degree in Computer Science or related Engineering fields. 5-10 years of demonstrated experience in reviewing and identifying gaps in architecture blueprints and designing controls, especially in the Cloud domain. Candidates with proven experience in financial services industry is preferred. Must be able to recommend mitigations to threat models based on threat vectors and exploits. Good knowledge and experience with regulations, including PDPA, MAS guidelines, and technology/cybersecurity regulations in other Asian countries (e.g., Thailand, Malaysia, Taiwan). Understanding of asset and/or wealth management businesses, including trade lifecycle and operational processes, is a plus. Certifications such as CISA, CISSP, and CCSP are encouraged and demonstrate continuous learning and application of standard methodologies. Ability to understand business requirements and security risks during security assessments and consultations. Understanding of the company's business direction from products, solutions, market, and technology perspectives in the Cloud domain. OTHER TRAITS Possess exceptional problem-solving and data analysis skills. Positive attitude and collaborative mindset. Highly motivated to stay updated with the latest developments in technology-related regulations and to acquire broad technical knowledge and skills. Strong communication, presentation, and interpersonal skills; ability to work collaboratively and effectively with employees at all levels in different geographies. A good team player in managing internal and external stakeholders to resolve issues and align with objectives. Exhibit proactiveness in identifying, articulating, and remediating gaps and issues.