Senior Quality Systems Engineer - Medical Device QMS Lead

Fisher Paykel Healthcare; Howick; On-site; NZD 120,000 - 180,000; Full time

Benefits offered by this job

Employee share plan

Profit sharing

Life insurance

Health insurance

Job summary

Fisher & Paykel Healthcare seeks a Senior Quality Systems Engineer to support the Airvo product group. You will guide design controls, drive QMS improvements, and ensure conformance for new and existing products across markets.

You will collaborate with design, development and product teams to enable robust quality outcomes and compliant commercialization, while mentoring others in quality leadership and regulatory requirements.

Qualifications

• 5+ years of experience in Quality Engineering or a related technical field.
• Experience in a highly regulated manufacturing/design environment; medical device experience advantageous.
• Strong knowledge of regulations for medical devices; electronic-focused regulations preferred.
• Experience applying quality principles to support business objectives and product outcomes.
• Experience leading quality initiatives or complex compliance activities.

Responsibilities

• Lead activities related to design controls and quality oversight for Airvo products.
• Drive implementation and continuous improvement of the QMS to maintain compliance.
• Ensure product quality to support efficient product commercialization.
• Provide guidance and support across the organisation on QMS matters.

Skills

Quality Engineering

Regulatory Knowledge

Design Controls

Stakeholder Management

Cross-functional Leadership

Problem Solving

Biomedical

Education

Bachelors in Science/Engineering

Tools

QMS Software

Job description

Fisher & Paykel Healthcare seeks a Senior Quality Systems Engineer to support the Airvo product group. You will guide design controls, drive QMS improvements, and ensure conformance for new and existing products across markets.

You will collaborate with design, development and product teams to enable robust quality outcomes and compliant commercialization, while mentoring others in quality leadership and regulatory requirements.