Quality Director

Planet Innovation (PI) is a globally recognised Healthtech Innovation and Manufacturing company. PI offers the full spectrum of product design, engineering and manufacturing services for its customers in the diagnostics, life sciences and healthcare industries. Our clients include many of the world's top medical device companies, as well as some of the world's most exciting medtech start-ups.

With HQ in Australia and the majority of its customers in the US, PI established a world-class manufacturing facility in Irvine, California in 2021 and this division is growing rapidly on the back of high demand for our production services by both existing and new clients.

PI has an authentic, transparent, supportive culture and we offer a broad array of comprehensive benefit programs for our employees, including medical, dental, vision, 401k with employer match, and paid vacation, holidays, and sick leave.

As part of our continued growth, we are looking for a Quality Director to join our manufacturing site in Irvine.

The Role

• The Quality Director is responsible for providing quality assurance support and leadership for the US business.
• Reporting to the Vice President (VP) QA/RA, the Quality Director 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, ISO 9001 and 21 CFR Part 820 requirements.

The Accountabilities

• Act as a subject matter expert and provide guidance to the US business in interpreting and executing against quality system elements to ensure compliance.
• Assist VP QA/RA in reporting to top management on the performance of the QMS and any need for improvement.
• Mentor and develop the US Quality Team.
• Work as a leader of the Quality Team to support ongoing global regulatory compliance including submissions.
• Ensure quality planning is conducted within the supporting US business units.
• 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 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, and DRM (Design for Reliability and Manufacturability) are all applied.

The Typical Experiences

• 6+ years in a Senior Medical Device QA role, or with at least 3 years in a managerial position within a contract manufacturing environment.
• Experience complying with international quality standards e.g., ISO 13485, ISO9001 and FDA QSR regulations.
• Degree in Science or Engineering.
• Working knowledge of ISO14971, IEC60601/61010, and IEC62304.

To Apply

A positive, high-achieving work culture, and plenty of opportunities to learn and grow await you at Planet Innovation, so apply now.

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.

Please note only applications with the right to live and work in the US will be considered for these positions.

No recruitment agencies, please.