Quality Specialist, OSSIS

Document & Record Control

• Maintain controlled QMS documents with accurate revision management and compliant distribution.
• Coordinate change control activities across documents, forms, processes, and quality records.
• Manage records for complaints, NCRs, CAPAs, validation files, and inspection reports in line with ISO 13485 and Global Document Control requirements.

Post-Market Surveillance (PMS)

• Manage the receipt, review, and processing of post-market complaints with timely documentation and follow-up.
• Support regulatory reportability assessments and the preparation of regulatory submissions.
• Work closely with Design & Development, Regulatory Affairs, Suppliers, and Operations to gather evidence for investigations.

Design & Process Control

• Support risk management activities, ensuring risk files remain current, traceable, and compliant.
• Assist with validation documentation, inspection activities, and Certificates of Conformance.
• Support inward / outward goods quality checks and collaborate with Operations and Marketing on product holds or quality queries.
• Provide technical input for design- or process-related investigations (e.g., imaging data, segmentation, machining).

Reporting & Quality Metrics

• Develop and maintain dashboards across complaints, NCRs, CAPAs, supplier quality, and audit readiness.
• Prepare quality reports for management reviews, internal meetings, and external audits.
• Deliver training on complaint handling, NCR / CAPA processes, and QMS expectations.

CAPA, NCR & Purchasing Controls

• Administer NCR and CAPA processes, ensuring timely root-cause analysis, action planning, and closure.
• Ensure strong traceability between complaints, NCRs, and CAPAs.
• Coordinate SCAR investigations with suppliers and manufacturing partners.
• Support supplier qualification, evaluation, and ongoing re-evaluation with Operations and Procurement.

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