Senior Quality System Engineer- Post Market Surveillance

at  Fisher Paykel Healthcare

ABOUT YOU

You will have the following skills and experience:

• A minimum of 4yrs Quality and Regulatory experience gained in the medical devices industry.
• A working knowledge of the FDA and international regulations that apply to the medical devices industry, i.e. EU MDR.
• Exposure to statistical and data analysis techniques and tools.
• Risk management experience.
• A deep understanding of the technical aspects of Quality and strong knowledge of its impact on the business.
• A tertiary qualification in Science or Engineering.

You will also have:

• An ability to build strong relationships with well-developed negotiation and influencing skills.
• Excellent communication skills with the ability to share complex ideas, positively influence, negotiate, and challenge with respect and diplomacy.
• A positive, practical attitude, project management skills and an ability to work at pace are critical to your success.

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.

Our Quality and Regulatory business group is dedicated to improving patient care and outcomes. The Post-Market Surveillance team within Quality and Regulatory drives this continuous improvement by monitoring our products and services in the market, raising awareness of any quality issues and risk management activities including corrective and preventative action, health hazard evaluations and product recalls. We also manage regulatory compliance in the 120+ countries we sell our products to.
We are seeking a talented and motivated Senior Quality Systems Engineer to join our Post-Market Surveillance team to identify, design and drive quality system improvements to assist the product groups in meeting goals and objectives and regulatory requirements for the medical devices industry.
If you are passionate about data analysis, trending, cross-team collaboration, risk management and monitoring the market’s pulse, this role offers a unique opportunity to make a significant impact in the medical device industry. You will work in a highly dynamic environment while constantly interacting with Product Development, Manufacturing, Regulatory and Quality teams in New Zealand and around the world.

In this role you will:

• Collect, analyze, and interpret post-market data to identify trends, anomalies, and potential product issues to support proactive product quality improvement initiatives.
• Collaborate cross-functionally with R&D, Regulatory Affairs, Clinical and Manufacturing teams to investigate and address potential post-market product concerns.
• Monitor the market landscape to stay ahead of emerging trends and regulatory changes impacting our products.
• Participate in the development of strategies for risk mitigation and continuous improvement.