
Senior Quality Systems Enginee..
2 weeks ago
**About The Role**
Our strong focus on research and development creates a regular flow of new Fisher & Paykel Healthcare products. To enable our ongoing success, we depend on the technical expertise of our Design Assurance team who ensure our products get to market as fast as possible while meeting customer, business and international regulatory requirements.
In the role of Senior Quality Systems Engineer (Senior QSE), you will provide technical engineering and quality system support to ensure design assurance of new and existing products within the Respiratory Humidification (RH) product group.
You will also lead activities related to the use of design controls, managing the implementation of our Quality Management System (QMS) to maintain compliance, and ensure product quality for effective and efficient product commercialization.
**About You**
We are looking for someone with:
- Minimum 5 years related experience in the medical device industry.
- A tertiary degree in Science or Engineering.
- Experience with product verification and validation activities.
- Knowledge and understanding of Risk management (ISO 14971).
- Knowledge and understanding of usability engineering (IEC 62366-1).
- Exposure to electronic medical device standards, including 60601-1 and collaterals.
- Familiarity and understanding of FDA and international regulations.
- A holistic approach to product development.
You will also have:
- Excellent communication skills with the ability to influence, negotiate and challenge with respect and diplomacy.
- An ability to build relationships at all levels within the organization.
**About Us**
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.
We focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) and Women in Engineering play an important role in this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women.
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