Sr QA Specialist; implantable medical device

Senior Quality Assurance Specialist - CAPA

Join a leading implantable medical device company as a Senior QA Specialist. In this role, you'll own the CAPA process, support audits, and ensure compliance with ISO 13485 and FDA regulations. This is not a software QA role - it's a hands-on quality position focused on product development, manufacturing, and regulatory documentation.

Key Responsibilities:

• Lead CAPA investigations and corrective/preventive actions.
• Support internal audits and quality planning.
• Drive compliance with ISO 13485, 21 CFR Part 820, and cGMP.
• Collaborate cross-functionally to uphold QMS standards.
• Participate in audit preparation and continuous improvement initiatives.

Qualifications:

• B.S. in Engineering (EE OR ME preferred)
• 5+ years in medical device or regulated industry (QA CAPA focused!)
• Strong knowledge of ISO 13485, FDA regulations, and risk management (ISO 14971)
• Skilled in technical writing, documentation, and problem-solving.
• Proficient in Microsoft Office; ability to prioritize and multitask.

Benefits:

• $90-95k base Depends on Experience + bonus
• Huge Room for Growth!
• Bonus Opportunity
• Regular Company Functions
• Vacation/PTO
• Full Benefits:
  Medical, Dental, Vision
• Amazing Work Environment
• HUGE room for growth (lucrative startup)
• A team of sharp people on the same mission
• Must be authorized to work in the US without Sponsorship
• 401(k)

For this position you must be currently authorized to work in the United States. We do not sponsor for this position.