Quality Associate

4 days ago

Box Hill, Australia Planet Innovation Full time

Planet Innovation (PI) is an award winning Healthtech Innovation and Commercialization company, and we work on some of the most advanced technology in the world. We have our own portfolio of businesses, and also partner with world-leading organizations to help them create game-changing innovations to grow their business. Our clients include some of the world's top medical device and healthcare companies, as well as some of the world's most exciting start-ups.

Creating great products and winning awards is all down to our team. Planet Innovation has over 500 of the brightest and most passionate people on Earth, and we are looking for more.

As part of our continuous growth, we are looking for a Quality Associate to join our Quality team working on product design and development.

**The Role**

The Quality Associate assists the Manufacturing Quality Assurance Manager and QA team to support the company’s overall Quality Management Systems based on ISO134585 and other standards relevant to the development, manufacturing, testing, auditing, and marketing of Planet Innovation's Products. Quality Associates also have the responsibility with “on the floor” implementation of quality assurance procedures and processes as well as assisting the broader PI team with respect to compliance

**The Accountabilities**:

- Evaluation and investigation of customer complaints
- Evaluation and investigation of nonconformances and CAPA
- Maintenance and support of document control procedures
- Custodian of the supplier management process
- Processing change orders in a timely manner with a high level of accuracy
- Review and authorise batch records (device history records) before products are released for distribution
- Coordination of the internal audit program - completing a number of Internal Audits as per the audit schedule
- Assisting and supporting in the design transfer and manufacturing readiness activities
- Improving and Maintaining the Tool and Process Validation requirements at PI

**The Typical Experiences**:

- 3+ years in a QA role, working within a regulated industry
- Knowledge of the US FDA, EU MDR & IVDR, and Australian TGA requirements, ideally with a record of approvals in these jurisdiction
- Graduate degree in relevant field (e.g. Mechatronics, Mechanical, Electronics, Software, Biomedical Engineering, Science etc.)

**Flexible Ways of Working**

We are proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees, and all suitably qualified applicants will receive consideration for employment without regard for race, gender, sexual orientation, religion, disability, or age.

No recruitment agencies, please.

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