Quality Specialist, OSSIS

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

As a Quality Specialist, you will play a critical role in ensuring the integrity, reliability, and continuous improvement of the Quality Management System (QMS) for OSSIS.

This role is ideal for someone with Quality Assurance experience in medical devices or another highly regulated industry who is looking to broaden their impact across compliance, operations, and quality improvement. You'll work cross-functionally, contribute technical expertise, and help ensure our products meet the highest standards for patient safety and regulatory compliance.

Management Control

• Maintain and enhance the QMS in alignment with ISO 13485, Zimmer Biomet global procedures, and MDR/TGA/Medsafe obligations.
• Support internal and external audits, including planning, coordination, evidence preparation, and closure of findings.
• Track and communicate key Quality performance indicators (complaints, NCR/CAPA status, audit readiness, training compliance).

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.

• Bachelor's degree in Life Sciences, Engineering, Quality, or a related discipline.
• 3–5 years' experience in Quality Assurance within medical devices or another highly regulated industry.
• Solid understanding of ISO 13485, MDR, TGA, Medsafe, or similar regulatory frameworks.
• Experience with complaint handling, NCR/CAPA processes, supplier quality management, and QMS documentation.
• Strong written communication, analytical, and investigation skills.
• Proficiency with Microsoft Office, SharePoint, and electronic QMS tools (e.g., Confluence/JIRA, document control systems).
• High integrity, proactive mindset, and strong organisational skills.
• A collaborative team player who takes ownership and delivers to a high standard

Limited travel may be required up to 5%

EOE/M/F/Vet/Disability