Quality Leader: CAPA & Management Review

Fisher Paykel Healthcare; Howick; On-site; NZD 90,000 - 140,000; Full time

Job summary

Fisher Paykel Healthcare is seeking a Quality Manager – CAPA & Management Review to join our NZ Quality Systems Central Services team. You will lead and coordinate CAPA and Management Review activities, ensuring the quality system operates effectively and risks are visible and actions completed.

You will also provide contingency support across Audit and Distribution Quality, collaborating with stakeholders and across functions to drive improvements and compliance with regulatory requirements.

Qualifications

• 4–6 years’ experience in the medical device or a similarly highly regulated industry.
• 4–6 years’ experience working with a Quality Management System.
• Knowledge and experience in CAPA, Management Review and related Quality Systems processes.
• Experience analysing quality data to identify trends, risks and improvement opportunities.
• Excellent verbal and written communication skills.
• Strong stakeholder engagement and influencing capability; regulatory knowledge.

Responsibilities

• Lead the day-to-day operation of the NZ CAPA process.
• Plan and coordinate Management Reviews and resulting actions.
• Monitor QMS performance, risks, trends and improvement opportunities.
• Provide clear Quality Systems reporting and recommendations to management.
• Partner with stakeholders to progress quality issues and actions.
• Support international sales and distribution quality activities.
• Provide contingency support for Audit and Distribution Quality.

Skills

CAPA knowledge

Management Review

Quality Systems

Stakeholder engagement

Communication skills

Regulatory knowledge

Job description

Fisher Paykel Healthcare is seeking a Quality Manager – CAPA & Management Review to join our NZ Quality Systems Central Services team. You will lead and coordinate CAPA and Management Review activities, ensuring the quality system operates effectively and risks are visible and actions completed.

You will also provide contingency support across Audit and Distribution Quality, collaborating with stakeholders and across functions to drive improvements and compliance with regulatory requirements.