Quality System Management (QMS) Provide oversight and continuous improvement for all elements applicable to 21 CFR parts 820, 210, 211: CAPA program including investigations and non-conformances, Design & Change Control, Complaint Handling including all applicable post-market surveillance activities, Product Quality Reviews / Annual Product Reviews, Supplier Quality Management, Internal Audit, Training, Data Integrity, Documentation Management, Risk Management. FDA Compliance & Inspection Readiness Ensure compliance with 21 CFR Parts 820, 210 and 211, FDA Guidance Documents, USP and compendial requirements, ISO 13485 and ISO 14971, where applicable.