Quality Department Manager

• Jul 2022 - Present

- Collaborate with clients' executive leaders regarding all operational goals and projects related to the development, validation, FDA-clearance, manufacturing, distribution, implementation, and maintenance of medical devices - Ensure compliance of all operations activities and procedures to each client's own quality management system and Title 21 CFR Part 820, ISO 13485, ISO 9001, ISO 17025, and/or ISO 14644 as appropriate - Oversee all annual and routine quality activities for each client's unique quality manual, quality objectives, and quality responsibilities (procedures, records, feedback, complaints, reportable events, etc.) based on their device's relative location in the medical product development lifecycle - Manage Technical, Quality, Regulatory and Doc Control teams' activities to maintain progress on multiple interdepartmental projects for all clients - Navigate regulatory pathways and compose procedures and records for maximum productivity, efficiency, and regulatory alignment while employing a risk-based, audit-ready analytical lens to inform all decisions and approaches