Sr QA Specialist (implantable medical device)

Location: 100% Remote | Industry: Medical Device

About the role

Join a leading implantable medical device company as a hands-on Senior Quality Assurance Specialist. This is not a software QA role—it focuses on product development, manufacturing, and regulatory documentation.

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.

Requirements

• B.S. in Engineering (Electrical or Mechanical preferred).
• 5+ years in medical device or regulated industry with a focus on QA CAPA.
• 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.
• Authorized to work in the U.S. without sponsorship.

Benefits

• Base salary: $90,000–$95,000.
• 5% annual bonus opportunity.
• Full benefits: medical, dental, vision.
• 401(k) retirement plan.
• Paid vacation/PTO.
• Regular company functions.
• Lucrative startup environment with significant growth potential.