Quality System Specialist

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 Quality System Specialist to join our team in Irvine.

The Role

The Quality Assurance Specialist assists the Quality Assurance and Regulatory team to manage the company's overall Quality Management Systems (QMS) such as ISO 13485, 21 CFR part 820, EU 2017/745 (MDR) EU 2017/746 (IVDR) and various other country specific regulations.

The Accountabilities

• Provide ongoing QA training support to the site to ensure a compliant training requirements management system.
• Create, maintain and update User accounts and training assignments in the eQMS
• Provide change order support to the manufacturing site to ensure a compliant training requirements management system.
• Communicate and support internal customers with the change order and training process.
• Participate in the review and update of standard operating procedures and work instructions.
• Lead and be responsible for evaluating, investigation and closure of Quality Management System activities such as Non-Conformance, CAPA and Customer complaints.
• Prepare and maintain key Quality Objective KPIs for the Quality Management Systems.
• Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs, EU MDR/IVDR (Design Control, CAPA, etc.), ISO 13485 and other national and international quality and regulatory requirements and standards
• Generate internal quality documentation such as Quality plans, Quality procedures and Work Instructions.
• Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.
• Provide training, awareness and support for quality system processes and quality engineering practices to PI wider team
• Evaluation, investigation and execution of change orders with a high level of accuracy
• Evaluation, investigation and execution of releasing documents
• Maintenance of document control procedures
• Archiving of documentation to ensure traceability and accessibility

The Typical Experiences

• Minimum 3 years Quality and experience within the medical device industry.
• Prefer one to two years of medical (ISO 13485) auditor experience.
• Previous Quality and Regulatory experience in the medical device industry or equivalent is a must.
• A team player and self-starter who will work side by side with the development team.
• Demonstrated ability to plan and priorities.
• High degree of independence in approach.
• Ability to multi-task, prioritize tasks and quickly adjust in a rapidly changing environment.
• Excellent verbal and written communication skills.
• Thorough working knowledge and experience in medical device standards such as ISO 13485, ISO 14971, IEC 62304 and IEC 62366 etc.
• Excellent computer skills.

$85,000 - $95,000 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.