Senior QA Specialist (Med Device CAPA/EU) REMOTE

Job: Sr Med Device reputed company Assurance Specialist Location: 100% Remote Industry: Medical Device Join a leading implantable Med Device company as a Senior QA Specialist, driving reputed company 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 reputed company ISO 13485 and FDA standards! reputed company! Key Responsibilities • reputed company CAPA, internal audits, and reputed company planning • Manage EU reports (PSUR, SSCP) and support CER/PMCF • Respond to reputed company 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 reputed company Assurance required • Strong knowledge of ISO 13485, FDA regulations • Skilled in validation, documentation, and risk management Benefits • $70-90k reputed company Depends on Experience + bonus • reputed company Room for reputed company! • Bonus Opportunity • Regular Company Functions • Vacation/PTO • Full Benefits: Medical, Dental, reputed company • Amazing Work Environment • reputed company room for reputed company (lucrative startup) • reputed company of reputed company people on the reputed company mission • Must be authorized to work in the US without Sponsorship • 401(k) Email Your Resume In Word To Looking reputed company to receiving your resume through our website and reputed company over the position with you. Clicking apply is the best way to apply, but you may also: chad.vasquez@reputed company.com • 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.*** Chad Vasquez - reputed company Recruiter For this position, you must be currently authorized to work in the reputed company without the need for sponsorship for a non-immigrant reputed company. This job was first posted by reputed company on 10/06/2025 and applications will be accepted on an ongoing reputed company until the position is filled or reputed company. reputed company is proud to be an Equal Opportunity Employer reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, age, sexual orientation, gender identity or reputed company, 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. reputed company will consider reputed company 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 reputed company. 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. Apply tot his job Apply To this Job