QA Engineer – Medical Devices & SaMD Compliance

Enovis Corp; Sydney; Vor Ort; AUD 70.000 - 110.000; Vollzeit

Benefits dieser Stelle

Competitive remuneration

Paid parental leave

Employee Assistance Program

Development opportunities

Zusammenfassung

Enovis Corporation is a medical technology company focused on advancing quality and patient outcomes. The Quality Assurance Engineer role is based in Frenchs Forest, NSW, and supports ISO 13485, ISO 14971, EU MDR and QMS compliance within the Enabling Techn group.

The job emphasizes production quality, post-market surveillance, complaint handling, audits, and ongoing maintenance of quality systems for orthopaedic devices and SaMD. Collaboration with cross-functional teams is essential.

Qualifikationen

• Bachelor’s degree in Engineering, Science or related field.
• 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.

Aufgaben

• 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
• 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.

Kenntnisse

Quality Assurance

Regulatory compliance

SOP documentation

Software as a medical device

ISO 13485

Microsoft Office

eQMS platforms

Ausbildung

Bachelor’s degree in Engineering, Science or related field

Tools

eQMS platforms

Microsoft Office

Jobbeschreibung

Enovis Corporation is a medical technology company focused on advancing quality and patient outcomes. The Quality Assurance Engineer role is based in Frenchs Forest, NSW, and supports ISO 13485, ISO 14971, EU MDR and QMS compliance within the Enabling Techn group.

The job emphasizes production quality, post-market surveillance, complaint handling, audits, and ongoing maintenance of quality systems for orthopaedic devices and SaMD. Collaboration with cross-functional teams is essential.