Judge Direct Placement is exclusively partnering with our client in the medical device industry on their Quality Systems Manager position. The ideal candidate will have a strong background in the medical device industry and an in-depth understanding of ISO 13485 standards. As a servant leader, you will be responsible for mentoring the quality engineering team, maintaining our quality systems and ensuring compliance with all regulatory requirements.
Key Responsibilities:
- Develop, implement, and maintain quality management systems in accordance with ISO 13485 standards.
- Serve as the primary quality representative for existing and prospective customers.
- Oversee compliance with medical device regulations, including MDR 2017/745/EU, FDA 21 CFR Part 820, and ISO 13485.
- Review and consolidate product requirements for medical device systems according to applicable regulations.
- Actively contribute to defining medical device documentation, from user needs to design verification testing.
- Work closely with Clinical Affairs to set up quality files suitable for pre-market clinical investigation.
- Collaborate with the Legal team to prepare manufacturing and quality agreements with external providers and suppliers.
- Perform quality audits and maintain all quality documentation related to products.
- Train and coach teams to use, follow, and work under QA processes.
- Oversee the risk management process and related activities.
Required Experience:
- A minimum of 5 years of experience in a similar position within the medical device industry.
- Proven track record of working under ISO 13485 quality management systems.
Qualifications:
- Bachelor degree in Engineering or relevant Life Science discipline.
- Detailed understanding USA medical device regulations.
Leadership Style:
- Must embody the principles of servant leadership, prioritizing the growth and well-being of team members and the communities to which they belong.
- Strong communication and interpersonal skills to lead and inspire the team.
