Sr Manager Design and Construction

Role: Senior Manager of Validation and Quality Systems in medical device/IVD manufacturing, ensuring compliance with FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304, and MDSAP standards. Responsibilities: lead validation programs, maintain audit readiness, coordinate process verification, and support product development teams; oversee system validation activities and process improvements in a regulated environment. Requirements: 5-7 years managing a team of 6-10 FTEs; extensive experience in medical device/IVD quality assurance, manufacturing, or engineering; strong knowledge of FDA, ISO, IEC, and risk analysis; proven leadership in continuous improvement and validation principles; excellent communication skills. Preferred: experience transitioning manufacturing lines from RUO to Dx/IVD; knowledge of statistics, DOE, and Six Sigma Black Belt or PMP certifications. HighValue: focus on validation, manufacturing, and quality assurance within FDA-regulated medical device/IVD environment, supporting product development and compliance. WorkSetup: not specified; salary range $155,600 - $233,400.