CyberCoders ยท 3 days ago
Senior QA Specialist (Med Device CAPA/EU) REMOTE
United States
Full-time
Remote
Mid, Senior Level
$70K/yr - $90K/yr
7+ years expCyberCoders is a leading implantable Med Device company, seeking a Senior QA Specialist to drive quality and compliance across product development and manufacturing. The role involves supporting audits, CAPA, and regulatory documentation while collaborating to uphold ISO 13485 and FDA standards.
RecruitingSearch Engine
No H1B
U.S. Citizen Only
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
Qualification
Required
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
401(k)
Company
CyberCoders
CyberCoders is a recruiting firm locating job positions across all industries, including finance, education, engineering and healthcare.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2013-12-02Acquired
Leadership Team
Nate Shuman
Lead Recruiter (Tech) CEO Club
Matt Miller
CTO
Recent News
2025-04-12
Company data provided by crunchbase