More jobs:
Quality System Specialist; Medical Devices
Job in
Plano, Collin County, Texas, 75086, USA
Listed on 2026-07-18
Listing for:
Peyton Resource Group
Full Time
position Listed on 2026-07-18
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
We’re seeking an experienced Quality Systems Specialist III to support and continuously improve our Quality Management System (QMS) in a regulated medical device environment. This role will lead QMS initiatives, manage CAPAs, support internal and external audits, maintain regulatory compliance, and partner cross-functionally to drive quality and process improvements.
Key Responsibilities- Maintain and improve the Quality Management System (QMS)
- Lead CAPA, non-conformance, and root cause investigations
- Coordinate FDA, ISO 13485, and EU MDR audits and inspections
- Develop and maintain SOPs, work instructions, and controlled documentation
- Track quality metrics and support Quality Management Reviews
- Partner with Manufacturing, R&D, Regulatory, and Supply Chain to ensure compliance
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 5+ years of Quality Assurance experience in the medical device industry
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and CAPA
- Experience with QMS software such as Master Control or Veeva
- Excellent communication, problem-solving, and audit management skills
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