Senior Quality Compliance Specialist

**Your role:**

+ Lead and support CAPA investigations end-to-end, including issue identification, root cause analysis (5 Whys, Ishikawa, statistical analysis), corrective actions, effectiveness checks, and closure in line with regulatory and QMS requirements.

+ Partner cross-functionally with Quality, Engineering, Manufacturing, Service and Commercial teams to ensure timely execution of CAPA actions, adequate resourcing, and sustained compliance.

+ Monitor and analyze quality data to identify risks, trends, and emerging non-conformances, enabling proactive compliance interventions and continuous improvement.

+ Strengthen the compliance culture by training and mentoring teams on QMS, CAPA, regulatory expectations, and best practices across the organization.

**You're the right fit if:**

+ You have a minimum of Minimum of 5+ years of experience in FDA regulated manufacturing/quality environments, with a focus on CAPA investigations, Pr...