Senior QA Specialist (Med Device CAPA/EU) REMOTE

Job: Sr Med Device Quality Assurance Specialist Location: 100% Remote Industry: Medical Device Join a leading implantable Med Device company as a Senior QA Specialist, driving quality and compliance across product development and manufacturing. This is NOT a software QA role. This role supports audits, CAPA, and regulatory documentation while collaborating cross-functionally to uphold ISO 13485 and FDA standards! Apply now! Key Responsibilities • Lead CAPA, internal audits, and quality planning • Manage EU reports (PSUR, SSCP) and support CER/PMCF • Respond to DEKRA inquiries and Notices of Change • Ensure compliance with ISO 13485 and 21 CFR Part 820 • Mentor junior QA staff and support cross-functional initiatives Qualifications • BSEE or BSME • 7+ years experience in Medical Device Quality Assurance required • Strong knowledge of ISO 13485, FDA regulations • Skilled in validation, documentation, and risk management Benefits • $70-90k 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 Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: [email protected] • 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.*** Chad Vasquez - 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. Apply tot his job