Quality Engineer

at  Zimmer Biomet

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, we focus on development opportunities, active employee resource groups (ERGs), flexibility, competitive rewards, Employee Assistance Program and a culture of recognition and performance incentives. We are committed to creating an environment where every team member feels included, respected, empowered, and recognised.
What You Can Expect
Are you ready to make a significant impact in the Med-Tech Industry?
Join a dynamic team at OSSIS in Christchurch, New Zealand, as a Quality Engineer on a fixed-term contract until April 2025. At OSSIS, we are committed to innovation, excellence, and patient safety, offering a supportive environment where your contributions are valued. You will have the opportunity to grow professionally while making a meaningful impact on the lives of patients worldwide.
How You’ll Create Impact

As a Quality Engineer, you will play a crucial role in ensuring our products meet the highest standards of quality and safety. You will be responsible for:

• Writing technical documentation to support regulatory submissions.
• Maintaining regulatory files and compiling submissions for various markets.
• Identifying regulatory market requirements for emerging markets.
• Preparing prompt responses to regulatory authorities’ queries.
• Reporting device-related incidents and handling recalls and field corrective actions.
• Reviewing labelling and marketing materials for regulatory compliance.
• Supporting audits and maintaining compliance with industry standards.

What Makes You Stand Out

• Bachelor’s degree in engineering or an alternative Bachelor’s degree with certification as a Quality Engineer (e.g.CQE).
• At least 2 years of experience in Quality Engineering, Quality Systems, or Supplier Quality
• Management, with a minimum of 1 year in the MedTech industry.
• Knowledge of ISO 13485 and familiarity with MDR.
• Strong technical writing skills and experience with regulatory submissions.
• Excellent communication and critical thinking skills.
• A proactive approach to problem-solving and a commitment to continuous improvement.

• Writing technical documentation to support regulatory submissions.
• Maintaining regulatory files and compiling submissions for various markets.
• Identifying regulatory market requirements for emerging markets.
• Preparing prompt responses to regulatory authorities’ queries.
• Reporting device-related incidents and handling recalls and field corrective actions.
• Reviewing labelling and marketing materials for regulatory compliance.
• Supporting audits and maintaining compliance with industry standards