Quality and Regulatory Assurance Manager

4 weeks 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.

Our global Quality and Regulatory Assurance (QA/RA) team is looking for a QA/RA Manager to support our PI Innovation Services function in Melbourne to design and develop regulated medical products and high-tech connected devices.

**The Role**

The QA/RA Manager is responsible for providing quality assurance support and leadership in the Innovation Services function in Melbourne. Reporting to the Vice President (VP) QA/RA, the QA/RA Manager is responsible for ensuring compliance with the Quality System and ensuring that the necessary actions are put in place to ensure ongoing compliance with current ISO13485 and 21 CFR Part 820 requirements.

**The team will rely on you to**:

- Assist VP QA/RA in reporting to top management on the performance of the QMS and any need for improvement with respect to product design and development.
- Mentor and develop the Innovation Services quality team.
- Work as a leader of the QA/RA team to support ongoing global regulatory compliance including submissions.
- Ensure quality planning is conducted within the supporting Innovation Services business unit.
- Ensure that all system-level project/program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, and reports) meet quality, reliability, and compliance requirements.
- Participate and collaborate with test engineers in the development, modification, and design review of Protocols, Data Summaries & Record.
- Conduct QA activities including audits, reviews of records, and quality awareness training.
- Participate in hazards and risk analysis studies of design and processes.
- Utilize risk management and robust design principles to identify essential design outputs / critical to quality (CTQ) attributes.
- Compile and analyze complaints, performance reports, and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Analyze preliminary plans and develops quality assurance programs to achieve company, customer, and governmental agency reliability objectives.
- Ensure Design Requirements Flow down, predictive modeling, and DRM (Design for Reliability and Manufacturability) are all applied.

**Ideally you have**:

- 4+ years in a Senior QA role, or with at least 2 years in a managerial position
- Experience in a highly regulated manufacturing industry, ideally medical devices
- Demonstrated experience in taking products to market, including regulatory approval.
- Experience complying with international quality standards e.g. ISO 13485, ISO9001 and FDA QSR regulations
- Degree in Science or Engineering
- Bonus points if you have good knowledge of Design Controls (D&D) and Manufacturing (MFG) requirements in medical devices, and if you have worked with ISO14971, IEC60601/61010, and IEC62304

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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