Fisher & Paykel Healthcare, Inc. Senior Quality Systems Engineer - Manufacturing in New Zealand
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 continuous improvement initiatives we need an experienced Quality Engineer. This is a great time to join a successful team, committed to improving patient care and outcomes.
About the role
As a Quality Engineer you will be working together with the manufacturing and design teams to provide technical and Quality support. Your responsibilities include managing the implementation of our Quality Management System (QMS) to ensure quality product and process design with effective design transfer to production. As well as being the point of contact for questions and support on the QMS, your skills in statistical analysis and problem solving will be well utilised. You will have a strong knowledge of validating test methods, and be an expert in corrective and preventative action.
Skills and Experience
- Science or engineering tertiary degree
- Minimum 4 years related experience in the medical device industry
- Understanding of FDA and international regulations
- Verification and process validation experience
- Exposure to statistical analysis techniques
- Ideally some experience in Lean 6-Sigma
- Excellent communication and negotiation skills
- Ability to build strong relationships at all levels within the organisation
Company & culture
Our success is due to a supportive and friendly culture that fosters innovation and 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!
Reference #: 42702
Posted on: 11 Sep 2017
Closes on: 06 Oct 2017 07:00
Location(s): New Zealand
Expertise: Quality/Regulatory Affairs
Job level(s): Indirect