Sr Manager, Quality Assurance
Role: Senior Quality Assurance Manager
Location: Irvine, CA (on-site)
Salary: $165k - $185k
EPM Scientific is partnered with a growing Class II implantable device company that recently raised $45M and are actively scaling both their product portfolio as well as their clinical footprint. Due to their growth, they are looking to bring on a Senior Quality Assurance Manager to play a key role in ensuring the QMS adheres to FDA, ISO, and internal quality standards. They are backed by a leadership team that has taken similar companies to major success and understand how and what to do to get there.
This is a chance to step into a high-impact role at a well-funded company with proven leadership, where you'll directly influence quality systems in a rapidly growing and highly specialized space.
Qualifications:
- Minimum 7 years of experience in a medical device regulated environment
- Strong knowledge and experience implementating and maintaining a QMS
- Direct management expereince
- Experience leading both internal and external audits
Responsibilities:
- Lead development, implementation, and maintenance of the QMS in compliance with FDA and ISO 13485 requirements
- Oversee complaint handling, investigations, and MDR activities
- Ensure proper execution of CAPA, nonconformance, deviation, and change control processes
- Partner cross-functionally with R&D, Operations, and Regulatory Affairs to support product development
- Provide training and mentorship to Quality team member and cross-functional stakeholders
Benefits:
- Competitive compensation package
- Medical, dental, vision insurance
- Bonus
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