Senior Quality Systems Engineer

2 weeks ago

East Tamaki, New Zealand Fisher & Paykel Healthcare Full time

**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.

Our commitment to excellence extends to our Quality Manufacturing team, an integral part of our operations. The Quality Manufacturing team plays a crucial role in maintaining high manufacturing standards and improving the efficiency and effectiveness of the manufacturing processes and systems. With a focus on continuous improvement and reliability, our Quality Manufacturing team is at the forefront of delivering products that make a positive impact on patient care and outcomes.

**About the Role**

In this exciting role as a Senior Quality Systems Engineer - Manufacturing for Respiratory and Acute Care (RAC), you'll actively collaborate with Operations, Production, and Process Development teams. Your QMS and statistical expertise will be key in providing training and guidance to uphold quality standards for both new and existing processes. Additionally, you will contribute to identifying and implementing improvements in our Quality Management System. A practical attitude, coupled with a willingness to collaborate, is crucial for success in this role, alongside a proactive nature and results-focused approach.

Offering involvement across every function of the business and exposure to a variety of products and manufacturing processes, this full-time position at our Auckland site will help you develop a strong understanding of the broader business. This sets the stage for an exciting array of career advancement options within F&P.

**Skills & Experience**
- 5+ years of work experience in Quality Engineering in the medical device industry.
- A tertiary qualification in Science or Engineering.
- Working knowledge of standards and regulations (ISO13485, ISO14971, 21 CFR Part 820, MDR).
- Experience with process and test method validation activities.
- Working knowledge of statistics and process improvement tools.
- Six Sigma or CQE certification is preferable.

You will also have:

- Excellent communication skills both written and verbal with the ability to share complex ideas, positively influence, negotiate, and challenge with tact and diplomacy.
- Strong problem-solving ability, (both through your own independent thinking and collaboration across the business) and a strong resilience when navigating problems.
- An ability to build relationships at all levels within the organization.

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