Quality Assurance Engineer

Enovis Corp; Sydney; On-site; AUD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive remuneration

Paid parental leave

Employee Assistance Program

Development opportunities

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

Regulatory compliance

SOP documentation

Software as a medical device

ISO 13485

Microsoft Office

eQMS platforms

Education

Bachelor’s degree in Engineering, Science or related field

Tools

eQMS platforms

Microsoft Office

Job description

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/