Quality Engineer, Medical Devices - CAPA & Compliance

Applied Medical Technology; Katherine; On-site; AUD 90,000 - 130,000; Full time

Job summary

Applied Medical Technology is seeking a Quality Engineer to develop, implement, maintain and support quality improvement and manufacturing programs. You will support CAPA and address customer complaints while ensuring compliance with GMP, ISO, and FDA requirements.

The role involves leading product quality investigations, data analysis, and collaboration across engineering, manufacturing and regulatory teams to drive improvement and maintain high-quality standards in medical device production.

Qualifications

• Four year degree in a technical discipline.
• 3-5 years experience in a regulated environment, preferably medical device.
• Proficiency with MS Office.
• Familiarity with mechanical and electrical test equipment.
• Knowledge of concepts, practices and procedures in medical device manufacturing.
• Ability to analyze and aggregate data using statistics.
• Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices.

Responsibilities

• Product testing and evaluation.
• Lead product quality investigations to a successful conclusion.
• Support CAPA program and address customer complaints.
• Perform risk assessments and provide management with recommendations.
• Provide technical guidance to QA/QC personnel.
• Interface with other departments to ensure CAPA completion.
• Ensure systems are compliant with GMP, ISO and FDA requirements.

Skills

Analytical thinking

Statistical analysis

Communication

Team collaboration

Education

Four year degree in technical discipline

Tools

MS Office

Mechanical & electrical test equipment

Job description

Applied Medical Technology is seeking a Quality Engineer to develop, implement, maintain and support quality improvement and manufacturing programs. You will support CAPA and address customer complaints while ensuring compliance with GMP, ISO, and FDA requirements.

The role involves leading product quality investigations, data analysis, and collaboration across engineering, manufacturing and regulatory teams to drive improvement and maintain high-quality standards in medical device production.