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Sr Quality Assurance Specialist; CAPA REMOTE
Remote / Online - Candidates ideally in
Pompano Beach, Broward County, Florida, 33072, USA
Listed on 2026-05-30
Pompano Beach, Broward County, Florida, 33072, USA
Listing for:
CyberCoders
Remote/Work from Home
position Listed on 2026-05-30
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
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Senior Quality Assurance Specialist - CAPA
Location: 100% Remote
Industry: Medical Device
Compensation: $90K-$95K + 5% Bonus
Join a leading implantable medical device company as a Senior QA Specialist. In this role, you'll own the CAPA process, support audits, and ensure compliance with ISO 13485 and FDA regulations. This is not a software QA role-it's a hands-on quality position focused on product development, manufacturing, and regulatory documentation.
Key Responsibilities:
- Lead CAPA investigations and corrective/preventive actions.
- Support internal audits and quality planning.
- Drive compliance with ISO 13485, 21 CFR Part 820, and cGMP.
- Collaborate cross-functionally to uphold QMS standards.
- Participate in audit preparation and continuous improvement initiatives.
- B.S. in Engineering (EE OR ME preferred)
- 5+ years in medical device or regulated industry (QA CAPA focused!)
- Strong knowledge of ISO 13485, FDA regulations, and risk management (ISO 14971)
- Skilled in technical writing, documentation, and problem-solving.
- Proficient in Microsoft Office; ability to prioritize and multitask.
- $90-95k 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)
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