Sr QA Specialist (implantable medical device)

a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; } Senior Quality Assurance Specialist - CAPA Location: 100% Remote Industry: Medical Device Compensation: $90K-$95K + 5% Bonus 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:

• reputed company 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 reputed company 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 reputed company Office; ability to prioritize and multitask.

Benefits

• $90-95k reputed company Depends on Experience + bonus
• reputed company Room for Growth!
• Bonus Opportunity
• Regular Company Functions
• Vacation/PTO
• Full Benefits: Medical, Dental, Vision
• Amazing Work Environment
• reputed company 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)

Email Your Resume In Word To Matt.Abbasfard@reputed company.com Looking reputed company to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply. Please do NOT change the email subject line in any way. You must reputed company the JobID: reputed company : CV6-1879531 -- in the email subject line for your application to be considered. Matt Abbasfard - reputed company Recruiter For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant reputed company. This is a new role. This job was first posted by reputed company on 10/06/2025 and applications will be accepted on an ongoing basis until the position is filled or closed. This job was posted on 10/06/2025 and is open for 60 days reputed company is proud to be an Equal Opportunity Employer reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national reputed company, reputed company, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. Our hiring process includes AI screening for keywords and minimum qualifications. Recruiters review reputed company results. reputed company will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. reputed company is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our reputed company at Benefits@reputed company.com to reputed company arrangements. Copyright 1999 - 2026. reputed company , Inc. reputed company rights reserved. Apply tot his job Apply To this Job