QA Technical Engineer - Regenerative Health Impact

Aroabio; Auckland; In loco; NZD 75.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

On-site gym

Birthday leave

Free parking

Public transport subsidy

WorkRide program

Bike shed

EV charging stations

Parental leave

Team events

Employee Share Plan

Career growth

Descrizione del lavoro

AROA NZ is seeking 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 cross-functional teams, drive root cause analyses, and contribute to continuous improvement in product quality and safety. Be part of a mission-driven company delivering innovative wound care solutions.

Competenze

• Bachelor’s degree in science or engineering.
• Experience in a similar Quality role in a regulated industry.
• Experience with computer system/software validation is a plus.
• Strong understanding of Quality Management Systems and cGMP is essential.
• Knowledge of ISO 9001 or ISO 13485 and 21 CFR Part 820.
• Experience in process validation or equipment qualification recommended.
• Proficiency in technical writing and documentation for compliance and clarity.

Mansioni

• Provide quality oversight and approval of validation activities and documentation.
• Engage with production processes, equipment, and personnel to uphold quality throughout design transfer and manufacturing.
• Collaborate with cross-functional teams to support multiple projects and meet deadlines.
• Serve as QA technical contact, drive root cause analysis, and communicate quality concerns to cross-functional teams.
• Contribute to continuous improvement of product quality and safety.

Conoscenze

Quality assurance

Regulated industry knowledge

Technical writing

Validation experience

Formazione

Bachelor’s degree in science or engineering

Descrizione del lavoro

AROA NZ is seeking 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 cross-functional teams, drive root cause analyses, and contribute to continuous improvement in product quality and safety. Be part of a mission-driven company delivering innovative wound care solutions.