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.

• Coach, train, and develop engineers to enhance problem-solving and technical expertise.
• Drive accountability and performance within the team, ensuring alignment with organizational objectives.

Quality & Compliance Management:

• Ensure compliance with ISO 13485, 21 CFR 820, and company quality policies.
• Manage the nonconformance process, ensuring thorough investigation, timely record completion, and driving nonconformance reduction.
• Oversee CAPA activities, ensuring robust root cause analysis (e.g., 5 Whys, Fishbone Diagrams) and driving corrective and preventive actions to closure.
• Support internal and external audits, providing documentation and implementing corrective actions as needed.

Manufacturing Support & Process Improvement:

• Collaborate with manufacturing, process engineering, and validation teams to drive quality improvements.
• Evaluate and approve proposed solutions, modifications, and process adaptations to maintain product quality.
• Lead process improvement initiatives using data analytics, Lean, Six Sigma, and other quality methodologies.
• Develop, maintain, and monitor KPIs for quality and manufacturing performance.
• Act as an internal champion for quality, ensuring production processes are optimized for compliance and efficiency.

Technical Expertise & Validation:

• Provide technical guidance in validation, process control, and risk management for manufacturing operations.
• Ensure production validation activities, including IQ/OQ/PQ, are effectively executed and maintained.
• Represent the Quality organization as the main technical contact for projects, interfacing with senior engineers, technicians, and cross-functional teams.

Strategic & Business Responsibilities:

• Participate in annual budgeting processes for the team, ensuring proper allocation of resources.
• Support training and cross-training initiatives to enhance skill sets within the quality engineering team.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor of Science (BS) in Engineering (Mechanical Engineering, Biomedical Engineering, or related discipline).

Experience

• Minimum 10 years of experience in quality engineering, production quality, or manufacturing engineering in a regulated medical device environment.
• Strong background in ISO 13485, 21 CFR 820, CAPA, and validation processes.
• Experience managing nonconformance processes and leading root cause investigations.
• Proven track record in driving continuous improvement initiatives and process optimization.

Skills

• Strong leadership skills, with experience in mentoring and coaching engineers.
• Excellent project management skills, with the ability to handle multiple priorities effectively.
• Deep knowledge of root cause analysis methodologies (5 Whys, Fishbone, etc.).
• Strong analytical and data-driven decision-making skills.
• Proficiency in Power BI and other data analysis tools.
• Strong interpersonal and collaboration skills, with experience working in cross-functional teams.
• Ability to effectively communicate technical concepts to engineers, technicians, and senior leadership.
• Driver for acquiring resources and building consensus across teams.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Demonstrated ability to interact with regulatory agencies.
• Familiarity with sterilization processes, cleanroom environments, and associated product testing.
• Regularly and effectively presents complex technical information/analysis and responds to questions from technical staff members and management.
• Knowledge and use of relevant PC software applications and skills to use them effectively.