Quality Systems Engineer / Senior Quality Systems Engineer

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

Benefits offered by this job

Employee share purchase scheme

Profit share & salary review

Generous parental leave

Health Insurance & life protection

Job summary

Fisher & Paykel Healthcare in Auckland, New Zealand, is seeking a Senior Quality Systems Engineer to lead Design Quality and QMS activities across our Infant Care, NIV, IVH and OSA product streams from our head office in Auckland. Immigration and relocation support will be provided to preferred candidates.

You’ll partner with Regulatory, Clinical, Operations and Product Development to ensure safe, effective and compliant devices while driving ongoing quality improvements and lifecycle activities.

Qualifications

• Experience or knowledge across Design Quality/Quality Engineering in medical devices.
• Knowledge of Design Controls and QMS incl. ISO 13485 and FDA.
• Proficiency in risk management per ISO 14971.
• Experience with verification and validation activities.
• Experience with change control and lifecycle activities.
• Ability to use data and statistics for risk-based decisions.
• Familiar with CAPA, usability engineering and EU regulatory requirements.
• Relevant Science or Engineering degree.

Responsibilities

• Provide quality leadership across product development and lifecycle.
• Act as SME in Design Controls and the QMS.
• Influence cross-functional teams on quality and risk decisions.
• Identify and drive QMS and continuous improvement initiatives.
• Provide training and guidance to others.
• Take a holistic view of product quality, regulatory compliance and business needs.

Skills

Design Quality

Quality Engineering

Design Controls

Quality Management Systems

ISO 13485

FDA requirements

Risk management

ISO 14971

Verification & Validation

Change control

Product lifecycle

Data & statistics

CAPA

Usability engineering

Regulatory knowledge (EU/International

Science or Engineering qualification

Education

Science or Engineering degree

Job description

Job description

Care to find solutions?

Join a team of good people doing good work with intent. People like you, who care to make a difference.

About The Opportunity

Our strong focus on research and development creates a regular flow of new and innovative medical devices. Our Design Quality teams work closely with Product Development and cross-functional teams to ensure our products meet customer, business and international regulatory requirements. We have opportunities across our Infant Care, Non-Invasive Ventilation (NIV), Invasive Ventilation & Humidification (IV&H) and OSA teams, based at our head office in Auckland, New Zealand. Immigration and relocation support will be provided to preferred candidates. The focus varies across our teams:

• Infant Care, NIV and OSA have a stronger focus on new product introduction (NPI) and product development, applying Design Controls as products progress through development, verification and validation, and towards market release. NIV and OSA primarily support mechanically based consumable products, while Infant Care also includes more complex capital products.
• IV&H has a stronger focus on sustaining and lifecycle activities, supporting established, higher-risk capital products and associated consumables. You’ll help maintain compliance and drive ongoing product and quality improvements.

Across all teams, you’ll partner with Product Development, Regulatory, Clinical, Operations, Marketing and other Quality teams to provide practical quality guidance and help deliver safe, effective and compliant products.

About You

We’re looking for Quality professionals with experience or knowledge across areas such as:

• Design Quality / Quality Engineering within medical devices or another highly regulated environment
• Design Controls and Quality Management Systems, including ISO 13485 and FDA requirements
• Risk management, including ISO 14971
• Product verification and validation
• Change control and product lifecycle activities
• Data and statistical analysis to support risk-based decision making
• CAPA, usability engineering and international/EU regulatory requirements
• A relevant Science or Engineering qualification

You’ll be a strong communicator who can build relationships, solve problems collaboratively and confidently influence and constructively challenge decisions while balancing quality, regulatory, product and business needs.

For Senior QSE opportunities

At Senior level, we’re looking for an experienced Design Quality professional who can operate as a trusted quality partner and:

• Provide quality leadership across product development and lifecycle activities
• Act as a subject matter expert in Design Controls and the QMS
• Influence cross-functional teams on quality and risk-based decisions
• Identify and drive QMS and continuous improvement initiatives
• Provide training, development and guidance to others
• Take a holistic view of product quality, regulatory compliance and business needs

Working With Us

Care to join a supportive environment? Fisher & Paykel Healthcare foster 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.

• Employee share purchase scheme
• Discretionary bi-annual Profit share & Annual performance-based salary Review
• Generous Paid Parental Leave
• Life, Critical illness and Income Protection Insurance
• Discounted Health Insurance & other Banking and Insurance discounts
• Active Social clubs & community groups
• In-house training programs from external providers & excellent career progression opportunities
• School holiday programme subsidy
• Free Parking, beautiful campus with green spaces & Subsidised Cafés
• Access to state-of-the-art facilities

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. Our commitment to care unites us. Here, we’re driven to improve patient care and outcomes through inspired and world-leading healthcare solutions.

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].