Supplier Quality Engineer

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.

We are looking for an experienced Supplier Quality Engineer to join our growing Quality team at our Irvine site.

The Role

• The Supplier Quality Engineer is responsible for providing quality assurance support and leadership in supplier qualification and maintenance.
• Reporting to the site quality manager, the supplier quality engineer is responsible for ensuring compliance of the Quality System with regards to supplier selection, supplier maintenance and supplier actions.
• Further ensuring that the necessary actions are put in place to ensure ongoing compliance with current ISO13485 and 21 CFR Part 820 requirements.

The Accountabilities

• Perform supplier assessment (audit) and participate in supplier selection to evaluate quality systems, processes, and services of suppliers.​
• Oversee supplier monitoring, Supplier Corrective Action Request (SCARs), supplier related Non-Conformance Reports (NCRs), and purchased part assessment, and evaluate impact of supplier change requests.​
• Perform component validations / qualifications utilizing statistical analysis tools including process capability and measurement system analysis, and tolerance interval analysis. ​
• Management of approved suppliers via the Approved Supplier List (ASL).​
• Work with R&D, Operations, and Procurement to ensure compliance for materials/components and services.​
• Support gaps at suppliers (e.g., supplier quality system and process development activities).​
• Navigate various government and industry standards to include FDA 21CFR part 820, ISO 13485, ISO 14971 and Good Manufacturing Practices (GMP). ​
• 25%-50% travel to supplier sites in the US or internationally.

The Typical Experiences

• 2+ years in a Supplier Quality role​
• Advanced knowledge in supplier quality system architecture​
• Experience complying with international quality standards e.g. ISO 13485, ISO9001 and FDA QSR regulations​
• Degree in Science or Engineering​
• ISO 13485 auditor certification desired

$105,000 - $145,000 a year

We offer our team 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.

Full time employees and dependents are provided with medical coverage, and the company covers 100% of the premium cost.

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.