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: • 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) Email Your Resume In Word To [email protected] Looking forward 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 keep the JobID: linkedin : CV6-1879531 -- in the email subject line for your application to be considered. Matt Abbasfard - Lead Recruiter For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa. This job was first posted by CyberCoders on 10/06/2025 and applications will be accepted on an ongoing basis until the position is filled or closed. CyberCoders is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, 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. CyberCoders 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. CyberCoders 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 Human Resources team at [email protected] to make arrangements. Copyright 1999 - 2026. CyberCoders , Inc. All rights reserved. Apply tot his job