Job Description

Care to find solutions?

Join a team of good people doing good work with intent. People like you, who care to make a difference.

About the opportunity

Is this the next step in your Quality or Engineering career? We have an opportunity to join our Post Market Surveillance team as a Senior Quality Systems Engineer (Senior QSE)! Our Quality & Regulatory team is dedicated to improving patient care and outcomes. The global Post-Market Surveillance team drives this continuous improvement by monitoring the safety and effectiveness of our products and services in the market, raising awareness of any quality issues, and informing risk management activities with executive management, including corrective and preventative action, health hazard evaluations and recalls.

As a Senior QSE you will be working in a highly dynamic environment ensuring effective interfaces with Product Development, Manufacturing, Marketing, Regulatory and Quality teams in New Zealand and around the world.

Your responsibilities will include:

• The identification and resolution of quality issues through the continuous review of Post Market Surveillance Data and appropriate risk analysis and assessment
• Providing support to the Product Development team(s) in addressing quality issues & process improvements.
• Assisting the Product Groups to meet the quality and regulatory requirements for Global Post Market Surveillance regulations
• Ensuring that products and processes within a functional groups operation, meet quality standards and specifications.

About you

• A science or engineering, or other relevant tertiary degree
• At least 5 years of Quality and/or Regulatory experience within a highly regulated environment
• Understanding of FDA and other international medical device regulations
• Experience in risk management and risk analysis
• Application of statistical & data analysis techniques & tools to inform decision making
• Excellent communication, negotiation and presentation skills
• Ability to build strong relationships and influence at all levels within the organisation

Working With Us

Care to join a supportive environment?Fisher & Paykel Healthcare foster an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems and do your best work, while enjoying some of our perks and benefits:

• Employee share purchase scheme
• Discretionary bi-annual Profit share
• Generous Paid Parental Leave
• Life, Critical illness and Income Protection Insurance
• Discounted Health Insurance
• Active Social clubs & community groups
• In-house training programs from external providers
• Purchasing privileges for Fisher & Paykel Healthcare
• School holiday programme subsidy
• Banking and Insurance discounts
• Free Parking
• Beautiful campus with green spaces
• Subsidised Café’s
• Annual Salary Review
• High rates of internal promotion

Care to join us? Apply today

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 WISE (Women in Science & Engineering) among others 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 Te Uru Tangata – Centre for Workplace Inclusion, Pride Pledge and Global Women.

We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at recruit@fphcare.co.nz