Fisher & Paykel Healthcare is hiring a Senior Quality Systems Engineer (Senior QSE) to join our global Post Market Surveillance team. In this role, you will be responsible for monitoring the safety and effectiveness of our products in the market, identifying quality issues, and informing risk management activities. You will work in a dynamic environment interfacing with Product Development, Manufacturing, Marketing, Regulatory, and Quality teams globally.
What You'll Do
- Identify and resolve quality issues through continuous review of Post Market Surveillance data and appropriate risk analysis and assessment.
- Provide support to Product Development team(s) in addressing quality issues and process improvements.
- Assist Product Groups to meet quality and regulatory requirements for Global Post Market Surveillance regulations.
- Ensure that products and processes within a functional group's operation meet quality standards and specifications.
What We're Looking For
- A science, 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 and data analysis techniques and tools to inform decision making.
- Excellent communication, negotiation and presentation skills.
- Ability to build strong relationships and influence at all levels within the organisation.
Team & Environment
You will be part of the global Post-Market Surveillance team within the Quality & Regulatory team.
Benefits & Compensation
- 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 and community groups
- In-house training programs from external providers
- Purchasing privileges for Fisher & Paykel Healthcare products
- 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
Work Mode
This role is onsite in New Zealand.
We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences.
