Quality Engineer / Quality Systems Specialist

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. Required Qualifications 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. #J-18808-Ljbffr Stark Pharma Solutions Inc