Quality Systems Engineer
3 days ago
**About the role**
As a Quality Systems Engineer you will be working together with Product development, Process development and Manufacturing teams to contribute to market acceptance of newly developed product using your technical and quality expertise to influence product quality.
Your responsibilities include leading activities related to the use of design controls, managing the implementation of our Quality Management System (QMS) to maintain compliance and ensure product quality and process design to have effective and efficient product commercialization.
**Skills and Experience**
- Minimum 2 years' experience in the medical device industry
- Quality experience is preferred but we will consider other engineering experience with medical device experience
- Excellent influencing and negotiation skills
- Ability to build strong relationships at all levels within the organisation
- Good understanding of Risk management (ISO 14971)
- Experience with verification and validation activities
- Understanding of FDA and international regulations (ISO 13485)
- Exposure to statistical analysis techniques
- Ideally some experience in design controls for mechanical and/or electrical or software within a medical device environment
- Ideally some experience in reliability engineering
- Science or engineering tertiary degree
**About the company**
Fisher & Paykel Healthcare is a world leader in the design, manufacture and marketing of medical devices, exporting to over 120 countries globally. We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acute care and the treatment of obstructive sleep apnea.
In response to business growth and new products under development we need an experienced Quality Systems Engineer. This is a great time to join a successful team, committed to improving patient care and outcomes.
**Company & culture**
Our success is due to a supportive and friendly culture that fosters innovation and an achievement driven and focused team. We offer great benefits and a commitment to developing our employees.
Working with like-minded people, located on landscaped grounds within New Zealand's biggest city and close to all New Zealand has to offer you'll wonder why you haven't made the move to work with us already
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