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