QA Technical Engineer: Validation, Equipment & Risk

Aroa Biosurgery Limited; Auckland; On-site; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Health & wellbeing

Birthday leave

On-site parking

Transit subsidies

Parental leave

Team events

Share plan

Career growth

Job summary

AROA Biosurgery Limited seeks a QA Technical Engineer to oversee quality assurance across manufacturing and project activities. You will provide essential technical quality oversight for validation, equipment qualification, and risk management.

Collaborate with production teams to ensure quality standards are upheld and drive root cause analyses for QA issues. The role requires a Bachelor’s degree in science or engineering, experience in a regulated QA environment, and knowledge of QMS and cGMP.

Qualifications

• Bachelor’s degree in science or engineering.
• Experience in a regulated QA role.
• Familiarity with quality systems and cGMP.
• Knowledge of ISO 9001/13485 and 21 CFR Part 820 is preferred.
• Experience with validation or equipment qualification.
• Strong technical writing and document review skills.

Responsibilities

• Provide quality oversight and approval of validation activities and documentation.
• Actively engage with production manufacturing processes, equipment, and personnel to ensure quality standards are upheld throughout design transfer and manufacturing.
• Collaborate with cross-functional teams and effectively 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 efforts by identifying areas for improvement in product quality and safety.

Skills

Quality assurance

Regulatory compliance

Software validation

Technical writing

cGMP knowledge

Education

Bachelor's degree in science or engineering

Job description

AROA Biosurgery Limited seeks a QA Technical Engineer to oversee quality assurance across manufacturing and project activities. You will provide essential technical quality oversight for validation, equipment qualification, and risk management.

Collaborate with production teams to ensure quality standards are upheld and drive root cause analyses for QA issues. The role requires a Bachelor’s degree in science or engineering, experience in a regulated QA environment, and knowledge of QMS and cGMP.