Quality Engineer, Medical Devices: Process Validation

AustCorp Executive; Western Australia; Vor Ort; AUD 90.000 - 130.000; Vollzeit

Zusammenfassung

AustCorp Executive is seeking a Quality Engineer to join its medical technology manufacturing team in Perth, WA. This hands-on role sits at the intersection of engineering, manufacturing and quality, supporting products from development through scalable production in a highly regulated environment.

You will drive process validation (IQ/OQ/PQ), CAPA and deviations, ensure ISO 13485 compliance, contribute to risk management and continuous improvement, and collaborate with Engineering,

Qualifikationen

• Degree in Engineering or related field.
• Experience in medical device quality engineering.
• Knowledge of ISO 13485 and regulatory requirements.
• Hands-on manufacturing process validation (IQ/OQ/PQ).
• Experience with CAPA, deviations and root-cause investigations.

Aufgaben

• Support manufacturing quality processes for medical devices.
• Lead process validation and equipment qualification (IQ/OQ/PQ).
• Ensure compliance with ISO 13485 and regulatory requirements.
• Investigate non-conformances and manage CAPA.
• Collaborate with engineering, manufacturing, R&D and quality teams.
• Develop validation protocols and manufacturing documentation.
• Support supplier quality and incoming quality requirements.
• Analyze performance and drive quality improvements.
• Participate in risk management and quality audits.

Kenntnisse

Quality engineering

Process validation

CAPA investigations

Regulatory compliance

Documentation

Risk management

Root cause analysis

Ausbildung

Engineering degree

Jobbeschreibung

AustCorp Executive is seeking a Quality Engineer to join its medical technology manufacturing team in Perth, WA. This hands-on role sits at the intersection of engineering, manufacturing and quality, supporting products from development through scalable production in a highly regulated environment.

You will drive process validation (IQ/OQ/PQ), CAPA and deviations, ensure ISO 13485 compliance, contribute to risk management and continuous improvement, and collaborate with Engineering,