Quality Audit Lead: Risk & Compliance

Fisher Paykel Healthcare; Howick; On-site; NZD 140,000 - 190,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit sharing (bi-annual)

Life, critical illness and income-prot

Discounted health insurance

Social clubs & community groups

In-house training programs

Purchasing privileges

Banking and Insurance discounts

Free Parking

Campus facilities

Annual salary review

Job summary

Fisher & Paykel Healthcare is seeking a Quality Manager – Audit to lead and continually improve the NZ campus audit programme. You will work with regulators and internal customers to drive QMS improvements and CAPA through risk-based auditing and strong stakeholder engagement.

You will mentor audit teams, coordinate internal and external audits, and report on audit performance to support Management Review and broader QA initiatives. This role is based in Auckland, NZ.

Qualifications

• Strategic and systems-focused thinker with ability to identify risks and improvement opportunities.
• Clear and confident communicator who builds trusted relationships with stakeholders.
• Strong leadership, coaching and influencing capability.
• Significant audit experience, ideally within medical devices or another highly regulated industry.
• Solid knowledge of Quality Management Systems and risk-based auditing principles.

Responsibilities

• Lead and continually improve the Quality Systems audit programme.
• Develop and maintain a risk-based audit plan that reflects regulatory, business and QMS priorities.
• Coordinate and support internal audits, external audits and regulatory inspections.
• Ensure audit findings, actions and follow-up activities are clearly documented, monitored and progressed.
• Analyse audit performance and trends and provide input into CAPA, Management Review and QMS improvement.
• Build audit capability across the business through training, coaching and practical guidance.
• Develop strong relationships with stakeholders across F&P and communicate confidently with auditors and regulators.
• Lead, coach and support the people contributing to audit programme delivery.

Skills

Strategic thinking

Communication

Leadership

Audit experience

Quality management

Risk-based auditing

Education

Bachelor's degree in Engineering, Science or related discipline

Job description

Fisher & Paykel Healthcare is seeking a Quality Manager – Audit to lead and continually improve the NZ campus audit programme. You will work with regulators and internal customers to drive QMS improvements and CAPA through risk-based auditing and strong stakeholder engagement.

You will mentor audit teams, coordinate internal and external audits, and report on audit performance to support Management Review and broader QA initiatives. This role is based in Auckland, NZ.