Design Quality Engineer

We are seeking a Design Quality Engineer to join our Quality team in Auckland, New Zealand to support design and development of active medical devices. Reporting to the Quality Manager, this role provides support to product development teams to ensure that medical devices are developed in accordance with requirements set forth by applicable regulations, standards and procedures. This role serves as the primary point of contact for quality input during product development.

Responsibilities:
  • Review documentation for all deliverables associated with design control and risk management activities
  • Participate in new product development activities for active medical devices by providing technical quality engineering support
  • Ensure engineering and scientific analyses are employed and design history files comply with company policies and applicable standards and regulations
  • Support risk management activities according to company policy, procedures and ISO 14971, including Risk Analysis and FMEA
  • Collaborate closely with project leads and project managers to support product development activities, such as design verification and design validation
  • Participate in design review and project planning meetings to ensure requirements for phase closure are quality requirements are considered from the initial development stages of product design

Knowledge, Abilities and Skills:
  • Tertiary qualification in a relevant scientific or engineering field
  • Minimum of 3 years related experience in the medical device industry
  • Good understanding of Quality System Regulations, ISO 13485 and ISO 14971
  • Knowledge of IEC 62366, IEC 62304 and IEC 60601 preferred
  • Good knowledge of design controls and risk management processes
  • Experience with quality/compliance standards within cGMP
  • Strong communication and interpersonal skills
  • Demonstrated problem solving and decision-making skills
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance
  • “Hands-on” self-starter with ability to work both independently and as part of a team

How to apply

Please email your CV and a cover letter to Richie.Christian@aroabio.com.

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