Quality Manager - 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

Quality Manager - CAPA & Management Review

An exciting opportunity has become available within our NZ Quality Systems Central Services team for a Quality Manager – CAPA & Management Review.

In this role, you will lead and coordinate key Quality System feedback and review activities, with primary responsibility for the effective operation of the NZ Corrective and Preventive Action and Management Review processes. You will ensure Quality Management System performance is effectively monitored, risks and issues are visible and escalated, and actions are progressed to timely and effective completion.

You will also provide contingency support across Audit and Distribution Quality, helping strengthen operational continuity across the Central Services team.

You will:

• 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.

About You

We are looking for someone with:

• 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.Knowledge of applicable regulatory requirements and QMS expectations.
• The ability to coordinate multiple priorities and drive actions through to completion.
• A collaborative and practical approach to working across functions and with management stakeholders.

Why Join Us?

Care to join a supportive environment? Fisher & Paykel Healthcare fosters an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems, and do your best work, while enjoying some of our perks and benefits:

• Employee share purchase scheme
• Discretionary bi-annual Profit share
• Annual Salary Review
• High rates of internal promotion
• 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 products
• Banking and Insurance discounts
• Free parking and subsidised cafes
• Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices

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.

We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at [e-mail]