6 Control Plans Jobs

1. A candidate with a minimum of 5 to 7 years of experience in Quality . 2.The position involves reviewing and managing PPAPs . 3. Experience in PPAP documentation review as per QPL standard for commodities like Sheetmetal, Fabrication, Casting, Forging, Hydraulics and Machining. 4.Strong in GD&T and ability to understand the drawings. 5. Competence in quality planning based on APQP, PPAP, PFMEA, Control Plan, MSA, SPC , Problem solving tools and techniques ( 7QC, 8D ) and Power BI is added advantage. 6.Assistin Pre-DPAR reviewstoassessmanufacturabilityandverifyqualitycompliance. 7. Supports Virtual RQA (Routing Quality Analysis) to assess and validate process routing for quality compliance. 8. Conducts Weld FMEA to identify and control risks in welding operations. Participates in WAAP (Welding As A Process) assessments to ensure robust and repeatable welding practices. 9. Develops and maintains detailed Control Plans to ensure process stability and product quality. 10. Utilizes SAP for managing quality data, notifications and inspection records. 11. Works with Windchill for document control and engineering change management. 12. Good English communication and the ability to handle the project independently with minimal guidance.

Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes related to the development, procurement, and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices, products, or services. Evaluate suppliers critical quality processes and ensure compliance with regulatory requirements and procedures. Drive supplier improvement via SQIPs (Supplier Quality Improvement Plans) and lead the Supplier Change Notice process with support from Engineering, Quality Engineering, Assurance, Qualify suppliers, assess their metrics, and audit their critical quality processes. Ensure validations are completed where specified and control plans exist to ensure sustained quality and compliance of supplied raw materials and components. Independently Produces and completes Supplier Quality Engineering related activities and documentation. Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met. Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality. Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results. Executes SCAR management, effective and timely closure Regulatory, ME, R&D, Clinical, etc. Experience in leading process improvement methodologies and organizational change management. Proven record of accomplishment in developing suppliers and implementing lean methodologies at supplier end. Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities. Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records Ensure raw materials/components/products at supplier(s) are released from supplier(s) according to the agreed requirements. Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE). Drive quality and compliance development and/or improvement at suppliers when needed. Required Skills and Qualifications: Bachelor's degree in engineering or science discipline, or equivalent experience. A minimum of up to 4 years of experience in establishing and maintaining regulated supplier management systems. Experience with APQP (IQ,OQ,PQ) preferred. Technical writing of protocols and reports. Experience in ISO 9001, 13485 a plus. Engineer quality and ensure compliance for raw materials, components, finished products etc. Certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer(CQE) and Certified Quality will be advantage. Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course will be added advantage. Excellent communication skills in English (written and verbal). Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing. Ability to drive progress, take initiative, and achieve results. Experience with technical drawings, specifications of parts. Experience in Manufacturing process of welding, soldering, crimping, injection molding, plating, casting, and thermal forming Effective communication skills in Mandarin and English. Ability to travel to supplier sites within assigned region. Ability to speak and communicate with local suppliers in native language (Mandarin) and in English.

The New Product Manufacturing Engineer (NPME) is responsible for ensuring smooth and compliant transition of new medical devices from design to manufacturing. This role plays a critical part in developing scalable, validated manufacturing processes, driving design for manufacturability (DFM), and executing Verification and Validation (V&V) activities in alignment with ISO 13485 and FDA 21 CFR Part 820. Key Responsibilities: Collaborate with R&D during the design phase to influence DFM and ensure manufacturability. Plan, execute, and document manufacturing Verification & Validation (V&V) activities, including equipment and process validations (IQ, OQ, PQ). Lead development of process documentation: PFMEA, control plans, work instructions, SOPs, and batch records. Develop manufacturing strategies, assembly procedures, and pilot line setups for new product introductions (NPIs). Drive tooling, fixture design, and automation planning for scalable and cost-effective production. Support and lead design transfer activities from engineering to manufacturing, ensuring production readiness. Participate in clinical builds and first article inspections (FAI), ensuring traceability and documentation compliance. Use statistical methods to analyse process capabilities and implement continuous improvements. Lead root cause investigations for manufacturing issues and support CAPA implementation. Collaborate cross-functionally with Quality, Regulatory, Supply Chain, and Production teams to ensure product launch timelines are met. Provide input and support for regulatory submissions related to manufacturing process and V&V outcomes. Qualifications: Bachelors degree in mechanical, Manufacturing, or Industrial Engineering. 5+years of experience in medical device manufacturing, new product introduction (NPI), and process development. Strong knowledge of Verification & Validation (V&V) principles and experience with IQ/OQ/PQ protocols. Familiarity with ISO 13485, GMP, and FDA 21 CFR Part 820. Proficiency with CAD (e.g., SolidWorks), ERP systems (e.g., Odoo, SAP), and statistical tools (e.g., Minitab, JMP). Demonstrated ability to write and review technical documentation for audits and regulatory submissions. Preferred Skills: Experience in Class II/III medical device product launches. Exposure to cleanroom practices and ESD-safe assembly. Hands-on experience in FMEA, and process optimization.

Manager – QA & QC with 6–9 yrs in automotive QA/QC, audits, SPC, MSA, NPD, IATF, AS9100D. Strong leadership, documentation, and supplier/customer handling. BE Mechanical/Electrical. Preference for Kannadiga candidates. Location: Kanakapura.

4–6 yrs experience in automotive component manufacturing. Must know IATF, AS9100D, SPC, MSA, FMEAs, and audits. BE in Mechanical/Electrical. Preference for Kannadiga candidates with strong problem-solving and communication skills.

Role & responsibilities Quality Assurance Engineer: Ensure compliance with FAI, PPAP, control plans, and quality procedures. Ensuring compliance with AS9100, ISO 9001, AS13100, and other customer specific requirements. Risk should identify upfront, Develop, implement, and monitor quality control processes to ensure product conformity. Conducting Process Capability Studies in FAI & Production stage with SPC (Cp, Cpk, GR&R, MSA) Implement in quality gauges & mistake-proofing techniques.( like gauge & position gauges., etc) Identify and address non-conformances (NCRs) and escapes, implementing Permanent corrective actions Preferred candidate profile Implementing AI-based vision systems, CMM automation, and inline inspection technologies Experience with CMM, GD&T, SPC, NDT, and metrology tools. Proficiency in quality tools like 8D, 5-Why, 7-QC tools, DMAIC, and PFMEA. Strong analytical, problem-solving, and communication skills. Qualifications & Experience: BE/B. Tech/Diploma in Mechanical (Mechanical, Aerospace, Industrial, or equivalent). Minimum 5 years of experience in Quality Assurance in aerospace manufacturing. Perks and benefits Statutory benefit such as Bonus, Gratuity, Insurance, Canteen and Transportation Contact Person : Manoj - 8618656208