More jobs:
Quality Engineer / Quality Systems Specialist
Job in
Durham, Durham County, North Carolina, 27703, USA
Listed on 2026-08-07
Listing for:
Stark Pharma Solutions Inc
Full Time
position Listed on 2026-08-07
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, Production QC/QA, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Contract Quality Engineer / Quality Systems Specialist
Location:
Durham, NC
Duration:
Long Term
We are seeking an experienced Quality Engineer / Quality Systems Specialist to support a fast‑paced FDA‑regulated medical device manufacturing environment. This role will focus on driving CAPAs, Non‑Conformances, investigations, and Quality System improvements while helping reduce quality backlog and ensuring compliance with regulatory requirements.
Key Responsibilities- Manage and drive CAPAs and Non‑Conformance investigations to timely closure.
- Support Complaint Handling, Audit Readiness, and Risk Management activities.
- Conduct root cause investigations and implement effective corrective and preventive actions.
- Ensure compliance with FDA regulations, ISO 13485, and internal Quality System requirements.
- Collaborate with Manufacturing, Engineering, and Quality teams to resolve quality issues.
- Support continuous improvement initiatives and maintain Quality Systems documentation.
- Experience in Quality Engineering or Quality Systems within the Medical Device industry.
- Hands‑on experience with CAPA, Non‑Conformances, Complaints, Audits, and Risk Management.
- Strong knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
- Proven root cause analysis and investigation experience.
- Excellent problem‑solving, communication, and documentation skills.
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