Quality Systems Engineer

3 months ago


East Tamaki, New Zealand Fisher & Paykel Healthcare Full time

**About the role**

Our Quality & Regulatory team is dedicated to improving patient care and outcomes. The global Post-Market Surveillance team drives this continuous improvement by monitoring 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. We also manage regulatory compliance in the 120+ countries we sell our products in.

We currently have a 10 month fixed term maternity cover opportunity for a motivated individual to join our team. As a Quality Systems Engineer you will be working in a highly dynamic environment while constantly interacting with Product Development, Manufacturing, Regulatory and Quality teams in New Zealand and around the world.

**Your responsibilities will be**:

- You will assist in 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 improvement projects.
- Assist the different 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.

**We are looking for someone with;**
- At least 2 years of Quality and Regulatory experience within a regulated environment
- Understanding of FDA and international regulations (ie EU MDR)
- Risk Management Experience
- Exposure to statistical & data analysis techniques & tools
- Excellent communication and negotiation skills
- Ability to build strong relationships at all levels within the organisation
- A science or engineering tertiary degree

**Our Company Benefits;**
- Employee share purchase scheme
- 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 and Medela 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

**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.

If you have a passion to grow and develop, we want to hear from you



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