Lead Quality Medical Devices

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

Accountability ClusterMajor Activities / Tasks

Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements.

• 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.

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.

• 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.

Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings.

• 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.

Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution.

• 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.

Ensure timely submission of quality documents to fulfil regulatory requirements

• Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents.

Major Challenges

1. 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.
2. 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.
3. 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.

Key Interactions

InternalExternal

• Third party Quality for developing documents/ SOPs/ policies related to EU MDR/ISO 13485 requirements/ CMO approvals in case of CMO audits performed/ Regulatory surveillance impact. (Daily or as required)
• IPD for development documents/ seeking inputs for preparing SOPs (Daily or as required)
• RA for regulatory requirements and technical file QA documents / seeking inputs for preparing SOPs/ Regulatory surveillance impact (weekly or as required)
• CMO for Site Quality management review data and for any product related queries (monthly or as required)
• SOP Management team for preparing and uploading SOPs/ related docs in Cipdox (daily)
• Vendor Quality For audit of Vendors supplying Medical devices and device components. For providing Inputs related to Quality Technical Agreement with Vendors supplying Medical devices and Device components/ Regulatory surveillance impact (Monthly or as required)
• System and Compliance For complaint handling of devices (weekly and as required)
• PV and DSD For post safety marketing requirements of medical devices (Monthly or as required)
• SCM/Finished product sourcing (FPS)/ Marketing for changes in device/product launch / complaints/ operational issues (As required)

• CMOs manufacturing Medical devices/IVDs and Device components such as Dr pack, Kaalmanns, Voxtur etc., (Monthly/ as required) for QMR/ collecting data required in QMR.
• Service providers who provide services related to manufacturing, testing, servicing, distribution of medical devices or IVDs as applicable for monitoring compliance to service agreements/ QTA (as required).
• Notified Bodies for ISO and CE Marking audits

Dimensions

• No. of Geographies: All across Cipla globally
• Obtain and maintain ISO certification and CE marking
• No major citation in Regulatory/ external (notified body) Audits affecting product supply

Key Decisions:

DecisionsRecommendationsDecision regarding content to be included in presentation in QMRRecommend content/ requirement to be included in SOPs related to medical devices prepared as per ISO 13485/ EU MDR requirements. Recommend proposed actions to non conformances received during audit Recommend actions to be implemented in response to updates in regulatory guidance / standards applicable to medical device/ IVDs as per Ciplas product portfolio. Approve/ Reject suppliers of components of medical devices, service providers engaged for medical devices/ IVDs. Approval / rejection of new contract manufacturing sites for medical devices/ IVDs from a quality stand point.Comments:

Skills & Knowledge

Educational qualifications:

B.Sc./ B. Pharm / MSc./ MPharm

Relevant experience:
At least 7 -10 years of experience in Quality of Medical Devices/IVDs / Drugs