Enovis Corporation (NYSE: ENOV) is an innovation driven medical technology company committed to creating a future of better care through groundbreaking products, software and solutions that help patients achieve extraordinary results.
Quality Assurance Engineer
The QA Engineer supports quality activities across the Enabling Techn group at Enovis to ensure compliance with Therapeutic Goods Administration (TGA) requirements, ISO 13485, ISO 14971, EU MDR and internal Quality Management System (QMS) standards.
Working as part of a global QA function, the role based in Frenchs Forest, NSW, focuses on production quality, post‑market surveillance, complaint handling, audit readiness and ongoing maintenance of quality and compliance for orthopaedic medical devices, with a focus on SaMD
Quality Assurance
Support compliance with ISO 13485, ISO 14971 and the company Quality Management System (QMS).
Assist with internal, external and TGA audits and inspections, including preparation, documentation and follow‑up actions.
Support the investigation and documentation of complaints, non‑conformances, CAPAs and risk assessments.
Maintain controlled documents and quality records in accordance with QMS requirements.
Contribute to quality and compliance training activities to promote awareness across the business.
Assist in Design Controls activities to support NPD projects
Evaluate nonconforming material and support disposition decisions in collaboration with engineering and manufacturing teams
Business & Cross‑Functional Collaboration
Partner with RA, Engineering, Sales, Operations, Marketing and other functions to provide practical QA guidance.
Participate in cross‑functional projects to ensure quality and regulatory requirements are identified and met.
Support alignment of local QA activities with global policies, procedures and standards.
About You
Bachelor’s degree in Engineering, Science or related field required
2+ years of experience in Quality Assurance or related function in the medical device industry
Working knowledge of ISO 13485 and quality system regulations
Strong technical writing skills and experience with controlled documentation
Experience with software as a medical device
Proficiency in Microsoft Office Suite and experience using eQMS platforms
Strong analytical and problem-solving skills
What’s in it for you?
Competitive remuneration package including Base Salary + Bonus.
Paid parental leave including 12 weeks paid leave + superannuation for the primary caregiver.
Access to Employee Assistance Program.
An engaging work environment that encourages continuous learning and development.
At Enovis we are focused onCreating Better Together!
Enovis is proud to be named one of'The Healthcare Technology Report's Top 100 Healthcare Technology Companies of 2023!'
At Enovis we value diversity, equity and inclusion. We are committed to providing a working environment where everyone is included and treated fairly and with respect.
For more information, please visithttps://ourpurpose.enovis.com/andhttps://enovis.com/
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Quality Assurance Engineer in Sydney employer: Enovis Corp
Enovis Corporation is an exceptional employer for Software Engineers, offering a dynamic work environment focused on innovation in medical technology. With a strong commitment to collaboration and scientific excellence, employees benefit from opportunities for professional growth while contributing to meaningful advancements in patient care. The inclusive culture fosters teamwork across diverse disciplines, making it an ideal place for those passionate about transforming healthcare through cutting-edge technology.
