[Remote] Senior QA Specialist (Med Device CAPA/EU) REMOTE
Note: The job is a remote job and is open to candidates in USA. CyberCoders is a leading implantable Med Device company, and they are seeking a Senior QA Specialist to drive quality 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 • 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 Skills • 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 • Must be authorized to work in the US without Sponsorship 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 • 401(k) Company Overview • CyberCoders is a recruiting firm locating job positions across all industries, including finance, education, engineering and healthcare. It was founded in 1999, and is headquartered in Irvine, California, USA, with a workforce of 201-500 employees. Its website is Apply tot his job