The Production Quality Engineering Manager will lead and manage a team of Production Quality Engineers in a Class II FDA-regulated medical device manufacturing environment. This role is responsible for ensuring compliance with ISO 13485 and 21 CFR 820, driving quality improvements in manufacturing, and managing validation activities. The manager will serve as a key technical contact for the organization, collaborating with cross-functional teams and interfacing with senior-level engineers and technicians on technical matters. This individual will be accountable for nonconformance management, corrective and preventive actions (CAPA), validation, data analysis and continuous process improvement.
The Production Quality Engineering Manager will serve as the subject matter expert (SME) for Production Quality and validations and will own the ongoing maintenance, execution, and continuous improvement of the Quality Management System (QMS) for their area.
ESSENTIAL DUTIES
Leadership & Team Management:
Manage and provide leadership for the Production Quality Engineering team, ensuring team development, effectiveness, and direction.
Quality & Compliance Management:
Manufacturing Support & Process Improvement:
Technical Expertise & Validation:
Strategic & Business Responsibilities:
MINIMUM QUALIFICATION REQUIREMENTS
Education
Experience
Skills
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