Responsibilities
- 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.
Requirements
- 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
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
