Manufacturing Quality Engineering Manager

Lead and manage manufacturing quality engineering activities in a regulated medical device environment, supervising quality engineering professionals, driving CAPA and MRB activities, conducting external supplier audits, and partnering cross-functionally to sustain manufacturing performance. Responsibilities include training, mentoring, goal setting, budgeting, developing and improving quality data systems, tracking quality objectives, and ensuring risk-based quality processes are implemented globally. Requires strong GMP knowledge, FDA/ISO 13485 familiarity, and ability to lead multiple quality initiatives while communicating effectively across functions and with regulators. Certifications such as Lead Auditor or Six Sigma are preferred.