Quality Assurance Engineer, Medical Devices & Validation

Aroa Biosurgery Limited; Auckland; On-site; NZD 90,000 - 115,000; Full time

Benefits offered by this job

Health & Wellbeing

Birthday Leave

Convenient Location

Sustainable Travel Support

Family-Friendly Benefits

Social & Team Culture

GROW TOGETHER Employee Share Plan

Career Growth & Impact

Job summary

AROA Biosurgery Limited is seeking a motivated Quality Assurance Engineer to join the Quality team in Auckland. You will oversee validation activities, qualification of equipment, risk management, and continuous improvement to ensure our wound care products meet the highest standards of compliance and safety.

In this role, you will interact with production floor processes, support design transfer, and collaborate with cross-functional teams to balance priorities and meet deadlines while

Qualifications

• Bachelor’s degree in Science, Engineering, or equivalent.
• 3+ years in Quality Assurance in the medical device, pharmaceutical, or other regulated industry.
• Strong understanding of Quality Management Systems (QMS) and cGMP.
• Working knowledge of ISO 13485 and 21 CFR Part 820.
• Hands-on experience with process validation.
• Strong technical writing and documentation review skills.
• Experience with or interest in computer system validation is desirable.

Responsibilities

• Provide quality oversight and approval of validation activities and documentation.
• Engage with production floor processes, equipment, and personnel to ensure quality standards are upheld throughout design transfer and manufacturing.
• Collaborate with cross-functional teams and support multiple projects, balancing priorities to meet deadlines.
• Serve as a point of contact for QA technical issues, drive root cause analysis, and communicate quality concerns to cross-functional teams.
• Contribute to AROA’s continuous improvement by identifying areas for improvement in product quality and safety.

Skills

Quality Assurance

Technical writing

Process validation

QMS / cGMP knowledge

ISO 13485 familiarity

Computer system validation

Education

Bachelor’s degree in Science or Engineering

Job description

AROA Biosurgery Limited is seeking a motivated Quality Assurance Engineer to join the Quality team in Auckland. You will oversee validation activities, qualification of equipment, risk management, and continuous improvement to ensure our wound care products meet the highest standards of compliance and safety.

In this role, you will interact with production floor processes, support design transfer, and collaborate with cross-functional teams to balance priorities and meet deadlines while