Lead - Medical Quality Devices

Job Description

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team for internal / external audit compliance for ISO and CE marking Responsible for surveillance of regulatory guidance/ standards applicable to medical devices in the respective geographies in which Cipla products are distributed. Key Accountabilities: Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements. Surveillance of new/updated regulatory guidance/ ISO standards applicable to medical devices as per Ciplas product portfolio to ensure compliance to latest regulations. Surveillance of EU noncompliance reports / CDSCO / USFDA etc that are applicable to medical devices manufactured by Cipla to enable continuous improvement. Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings. Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution. Ensure timely submission of quality documents to fulfil regulatory requirements. Major Activities / Tasks: Develop and establish Management responsibility system as per ISO 13485 and EU MDR Develop and establish design control system for EU market. Develop and establish key performance indicators (KPIs) for monitoring site performance and effectiveness of QMS as per ISO 13485. Prepare SOPs, Quality manual etc.as per ISO 13485/ EU MDR. Responsible to maintain compliance to ISO 13485 by adhering to SOPs and ensuring control and oversight over adherence by respective depts to SOPs. Periodic review of SOPs related to medical devices as per regulatory requirements and update. Arrange training and promote awareness among cross functional teams on ISO 13485 QMS and CE Marking Ensure readiness from QMS standpoint for internal and external audits. Provide guidance and support during internal and external audits examining compliance to EU MDR/ISO 13485 requirements. Co-ordinate with cross functional teams for internal/ external audit compliance. Create library of ISO standards. Review new/upcoming/ draft/ revised/ final regulatory guidance/ ISO standards related to medical devices applicable as per Ciplas product portfolio. Gap assessment of the guidance / standards in comparison to QMS at Cipla and identify suitable actions prior to implementation of the guidance/standard. Monitor implementation of the actions to enable continuous improvement. Schedule quality management review (QMR) meeting for medical devices. Collate data required for the QMR and prepare the presentation on site performance to monitor effectiveness of Quality management system. Appraise management representative regarding critical issues. Monitor implementation of the action plans derived from QMR by coordinating with other cross functional team. Audit of Vendors supplying Medical devices and Invitro diagnostic kits, completing audit documentation and verifying actions taken by the audited site to correct non-conformances observed. Audit of CMOs manufacturing medical devices, completing audit documentation, and verifying actions taken by the audited site to correct non-conformances observed. Audit of outsourced activities related to medical devices manufacturing/ servicing/ testing/ distribution. Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents. Major Challenges: Establishing Quality Management System for Medical devices according to EU MDR / ISO 13485 is new for Cipla, hence developing and maintaining it will be a challenge. Cross functional support is key in ensuring adherence to QMS, as challenge is awareness about EU/ ISO 13485 certification requirements is low in cross functional teams such as IPD/ RA/ SCM/FPS/ DSD, Marketing. Same can be overcome by promoting awareness about EU MDR/ISO 13485 requirements at the outset/ from time to time. Engage in Notified bodies audits for ISO and CE marking audits and coordinate with all Cipla teams for audit management. Coordinate with Cipla team for audit compliance. Skills & Knowledge: Educational qualifications: MSc./ MPharm/ if MTech then in Biomedical engineering; Certificate courses/diploma in ISO audits highly welcome Relevant experience: At least 9-10 years of experience in Quality of Medical Devices/IVDs /Implants Experience in regulated market product approvals e.g. US FDA is a high plus