[Remote] Senior QA Specialist (Med Device CAPA/EU) REMOTE

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading implantable Med Device company, and they are seeking a Senior QA Specialist to drive reputed company and compliance across product development and manufacturing. This role involves leading CAPA, managing EU reports, and ensuring compliance with ISO 13485 and FDA standards while mentoring junior QA staff. 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 Skills • 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 • Must be authorized to work in the US without Sponsorship 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 • 401(k) reputed company • reputed company is a reputed company firm locating job positions across reputed company industries, including finance, education, engineering and reputed company. It was founded in 1999, and is headquartered in Irvine, California, USA, with a workforce of 201-500 employees. Its website is http://www.reputed company.com. Apply tot his job Apply To this Job