Sr. Quality Engineer - CAPA

Candidates must possess a Bachelor's Degree or equivalent quality/regulatory experience, with a minimum of 5 years in a Quality or Regulatory role. A minimum of 3 years of experience with Corrective Action and Preventative Action (CAPA) and Nonconformance (NC) activities within a medical device or equivalent healthcare company is required. A deep understanding of CAPA and NC systems, associated regulatory requirements, previous experience in Issue Escalation (including Field Risk Assessment and Health Hazard Evaluation), and experience in a medical device with working knowledge of ISO 13485, FDA 21 CFR 820, and European Union MDD/MDR are essential. Strong investigational, problem-solving, and project management abilities are necessary, along with excellent communication, interpersonal skills, attention to detail, timeliness, and basic statistical methods including trend analysis. The ability to build rapport across functional teams and work comfortably at all organizational levels is also required.