Manufacturing | Process Validation | ISO 13485

Location: Perth, WA

Employment: Full-time

Help bring innovative medical technology into commercial manufacturing
An exciting opportunity is available for an experienced Quality Engineer to join a growing Australian medical technology business focused on developing and manufacturing advanced medical devices.

This position offers the opportunity to work at the intersection of engineering, manufacturing and quality, supporting innovative products as they progress from development into scalable, compliant production.

We are looking for a practical, technically capable professional who understands the challenges of manufacturing medical devices in a highly regulated environment.

You will be instrumental in ensuring manufacturing processes are robust, validated and capable of consistently delivering high-quality products.

The Opportunity

Working collaboratively with Engineering, Manufacturing, R&D; and Quality teams, you will support manufacturing quality, process validation, continuous improvement and regulatory compliance.

This is a hands-on role suited to someone who enjoys problem-solving, implementing practical improvements and taking ownership of quality engineering activities.

Key Responsibilities

- Support the development, implementation and optimisation of manufacturing quality processes for medical devices.
- Drive process validation and equipment qualification activities, including IQ, OQ and PQ.
- Ensure manufacturing activities and documentation comply with ISO 13485 and relevant regulatory requirements.




- Lead and support investigations into non-conformances, deviations and manufacturing quality issues.
- Manage CAPA activities, root-cause analysis and corrective actions.
- Work closely with engineering teams to support design transfer and the introduction of new products into manufacturing.
- Develop and maintain validation protocols, technical reports, quality procedures and manufacturing documentation.
- Support supplier quality, component specifications and incoming quality requirements.
- Analyse manufacturing performance, identify process variability and implement improvements to product quality and manufacturing yield.
- Contribute to continuous improvement initiatives focused on quality, productivity and operational efficiency.
- Participate in risk management, change control and quality audits as required.

About You
To be successful, you will ideally possess:

- A degree in Engineering, Biomedical Engineering, Manufacturing, Science or a related technical discipline.
- Demonstrated quality engineering experience within medical device manufacturing.
- Strong working knowledge of ISO 13485 and medical device regulatory requirements.
- Hands-on experience in manufacturing process validation, including IQ/OQ/PQ.
- Experience managing non-conformances, CAPA,



deviations and root-cause investigations.
- Knowledge of manufacturing process controls, engineering change management and risk management.
- Experience working collaboratively with manufacturing, R&D;, engineering and quality teams.
- Strong technical documentation, analytical and problem-solving skills.
- A proactive, practical approach to improving manufacturing quality and compliance.

Highly Regarded

- Previous experience supporting medical device manufacturing scale-up.
- Knowledge of FDA quality and regulatory requirements.
- Experience with ISO 14971.
- Familiarity with statistical process control (SPC), Cp/Cpk and design of experiments (DOE).
- Exposure to automated manufacturing and complex technical products.
- Lean Manufacturing or Six Sigma experience.
- Experience with supplier quality engineering and external manufacturing partners.

Why Consider This Opportunity?

- Join an innovative Australian medical technology setting.
- Work with advanced products designed to improve healthcare outcomes.
- Play an important role in establishing robust manufacturing and quality processes.
- Collaborate with multidisciplinary technical and scientific teams.
- Gain exposure to new product development, validation and manufacturing scale-up.
- Contribute to meaningful projects where quality engineering expertise is genuinely valued.

Interested?
If you're an experienced Quality Engineer with a background in medical devices and a passion for improving manufacturing processes, we'd welcome a confidential conversation.

📌 Senior Quality Engineer - Medical Devices (Perth)
🏢 Austcorp Executive
📍 Perth