Senior Quality Systems Engineer
3 days ago
**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.
**About the role**
As a Senior Quality Systems Engineer (QSE) you will be collaborating with Product development to release newly developed products to various markets. You will also support the conformance/compliance of existing products in their markets. Using your technical and Quality expertise you will ensure design assurance of new and existing products.
**Skills and Experience**
- Science or engineering tertiary degree
- Minimum 4 years related experience in the medical device or similarly regulated industries
- Excellent influencing and negotiation skills
- Ability to build strong relationships at all levels within the organisation
- Ability to have a holistic approach to product development
- Good understanding of Risk management (ISO 14971)
- Experience with verification and validation activities
- Understanding of quality management systems such as 21CFR820 and ISO 13485
- Exposure to statistical analysis techniques
- Ideally some experience in design controls for mechanical/electrical medical devices
- Ideally some experience in reliability engineering
**Company & culture**
Our success is due to a supportive and friendly culture that fosters innovation. We are proud to have an achievement driven and focused team. We offer exceptional 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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