Develop, implement, and maintain the QMS in alignment with ISO 13485:2016 standards. Create, review, and update QMS documentation, including quality policies, procedures, and work instructions.Support during External (Notified Body for ISO 13485:2016) and Corporate Audits and Provide real-time support to the notified body (ISO 13485:2016) and corporate auditors by delivering requested documents, records, and evidence.
Plan, conduct, and support internal audits to assess compliance with ISO 13485:2016 and applicable regulations. Directly Monitoring the QA KPI’s and help team achieve that, team management
Management review meeting presentation draft and support to present to ILT. Managing NC & CAPA in TrackWise and support stakeholder to conduct root cause analysis for any quality issues.
QA Stakeholder management (SCM, Sales, Business Development, ICM), training Management in Stryker India regarding QMS procedure through SLMS & implement and maintain risk management processes as per ISO 14971 (when applicable). Conduct risk assessments and ensure mitigation plans are integrated into the QMS. Execute, Implement and support marketing team as per Collateral Review process as per UCMPMD regulations.
Support ICM team for onboarding Indirect channel partner as per corporate requirement. Conduct supplier audits to ensure compliance with quality standards (e.g., ISO 13485:2016) and corporate QMS requirement.
Collaborate with suppliers on corrective action plans for non-conformances. Maintain Supplier Audit plan & monitor supplier performance through scorecards and KPIs.
Support supplier onboarding and qualification processes. Implement and maintain validation processes in warehouse and Service center & conduct quality checks on repaired or serviced products at national & regional service centers. Develop and maintain SOPs and work instructions for service operations.
Monitor adherence to service quality KPIs (e.g., defect rates, turnaround times). Investigate and resolve quality-related complaints or issues in the service process. Lead internal audits and support external audits related to the service center. Implement corrective and preventive actions (CAPAs) for quality improvements. Stakeholder management with division service center teams.
Implement and maintain validation processes in warehouse and Service center & conduct routine quality inspections of inbound, stored, and outbound materials/products. Verify that all materials meet defined quality specifications before storage or shipment.
Maintain accurate records of quality checks and non-conformances. Coordinate with Stryker division and suppliers to resolve material quality issues. Support RA and warehouse team for proper labeling, storage conditions, and handling of materials in line with regulatory standards. Conduct periodic inventory audits to identify and address discrepancies.
What you need
Master’s in pharmacy with minimum 10 years of experience in QMS, preferably in the medical device industry.
Strong analytical and problem-solving skills.
Proficiency in QMS software and tools.
Ability to manage multiple priorities in a fast-paced environment.
Required:
In-depth understanding of ISO 13485:2016 requirements and its application.
Familiarity with regulatory requirements (e.g., FDA, D&C Act and Rule, MDR 2017).
Experience with risk management principles (ISO 14971) and validation processes.
