_{04th September, 2026}

This is an excellent opportunity for an experienced medical device quality professional to take ownership of quality across the design and development lifecycle.

Working closely with R&D, Regulatory and other technical teams, you’ll lead the Design Quality function, ensuring new and evolving products meet global regulatory requirements while maintaining practical, robust design and risk management processes.

This is a senior and influential role combining people leadership with technical quality expertise. You’ll have the opportunity to shape quality processes, develop your team and have a genuine impact on the development of innovative medical devices.

What you’ll be doing

• Lead, mentor and develop the Design Quality team, building capability, accountability and strong quality ownership.
• Provide quality leadership across medical device design and development, including design controls, risk management and design changes.
• Partner with R&D across design inputs and outputs, verification, validation, design transfer and cross-functional design reviews.
• Oversee quality activities relating to usability, software, electrical systems, materials, specifications and associated design documentation.
• Maintain and continuously improve relevant areas of the QMS, ensuring compliance with global regulatory requirements and readiness for audits and inspections.

What we’re looking for

• A bachelor’s degree in science, engineering or another relevant technical discipline.
• At least 8 years’ quality experience within the medical device industry, including strong design and development quality experience.
• Around 5+ years’ leadership experience, with a proven ability to coach, develop and build capability within a team.
• Strong working knowledge of medical device design controls, risk management, ISO 13485, cGMP and FDA 21 CFR Part 820 requirements.
• Excellent communication and problem-solving skills, with the confidence to work across R&D, Regulatory and senior leadership; FDA/ISO audit experience is highly regarded.

Why join?

• Take a senior role with genuine influence over medical device design and development.
• Work closely with R&D and technical teams on innovative products from early design through to commercialisation.
• Lead and develop a specialist Design Quality team.
• Work within an organisation where quality is integral to product development and business success.
• Join a collaborative environment that values innovation, practical problem-solving and continuous improvement.

How to apply
  
Click APPLY NOW or call Belinda at  Scitex Recruitment on 09 200 3121  for a confidential discussion.
  
To apply for this vacancy, you MUST be a New Zealand citizen, or resident, or have already secured the right to work in New Zealand and therefore hold a valid visa.
  
Scitex specialises in permanent, contract and temporary recruitment – and has done so since 1987. We are here to engineer better Mondays.

#SCR-belinda-mckenzie
  

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