Capa Specialist

Position: CAPA / Nonconformance Specialist Location: Fully Remote (NC) Company: United Pharma Technologies Inc Industry: Medical Device Job Description: We are seeking an experienced CAPA / Nonconformance Specialist with strong medical device industry experience, particularly in retrospective nonconformance investigations, CAPA management, and root cause analysis . Key Responsibilities: Review, investigate, and document retrospective Nonconformances (NCs). Perform Root Cause Analysis (RCA) and develop effective CAPA plans. Support nonconformance investigations, risk assessments, and remediation activities. Ensure compliance with FDA regulations, ISO 13485, and medical device QMS requirements . Drive timely closure of NCs and CAPAs with proper documentation. Collaborate with Quality and cross-functional teams to resolve quality issues. Required Skills: Strong experience in the Medical Device industry . Hands-on experience with CAPA and Nonconformance Management . Direct experience handling Retrospective NCs / NC Remediation . Root Cause Analysis, investigations, and risk assessments. Knowledge of FDA regulations and Quality Management Systems (QMS). Strong technical writing and documentation skills. Pay Scale: $50 to $55/Hr on W2 Benefits: Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements. Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums. Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided. Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.