Sr Manager, Manufacturing Quality Engineering

Sr Manager, Manufacturing Quality Engineering

The Senior Manager, Manufacturing Quality Engineering provides leadership in ensuring robust, compliant, and efficient manufacturing processes that consistently produce products meeting validated requirements and established specifications. This role oversees manufacturing quality engineering activities across new product development, sustaining engineering, and manufacturing, driving process optimization, regulatory compliance, and continuous improvement. The position collaborates closely with manufacturing operations and global R&D business units to align quality initiatives with strategic objectives to enhance product reliability and overall product performance.

• Lead and support risk management activities, including FMEAs and risk assessments, ensuring product safety and reliability throughout manufacturing and design transfer.

• Manage quality engineering activities for new product development and sustaining engineering, including Process Readiness Evaluation (PRE), process validation, risk management, and design transfer, ensuring compliance with regulatory standards.

• Provide oversight of product and process testing methodologies, including Test Method Validation (TMV), while driving the implementation of advanced statistical analysis techniques such as Gage R&R, SPC, and DOE to optimize manufacturing processes, enhance product quality, and foster a culture of continuous improvement through lean manufacturing and Six Sigma principles.

• Support CAPA, non-conformance investigations, and corrective action initiatives to resolve quality issues and prevent recurrence.

• Support the integration of a unified Quality Management System (1QMS) within the manufacturing facility, ensuring alignment with global quality standards, regulatory requirements, and industry best practices.

• Develop and drive department strategy, establish procedures, and align quality initiatives with broader organizational objectives.

• Define, track, and analyze key performance metrics to drive continuous improvement in manufacturing quality.

• Implement and scale best practices across manufacturing site to drive consistency, quality, and operational excellence.

• Partner with manufacturing and R&D leadership to ensure alignment of quality initiatives with business priorities and operational execution.

• Provide subject matter expertise in quality, reliability, validation, risk management, and industry best practices throughout the product lifecycle.

• Support regulatory audits, compliance initiatives, and remediation efforts to ensure adherence to ISO 13485, FDA 21 CFR 820, and other industry regulations.

• Supervise, mentor, and develop manufacturing quality engineering leads, providing guidance, performance evaluations, and professional growth opportunities that support a fit-for-purpose organization.

• Recruit, hire, onboard, and train new team members to meet resource needs and strengthen team capabilities.

• Apply project management expertise in cost, scheduling, and resource planning to execute quality initiatives and support product development.

• B.A. or B.S. degree in a technical discipline, such as engineering or science.

• Advanced degree such as M.S. or M.B.A preferred.

• 15+ years of relevant industry experience (e.g., quality engineering, manufacturing, or a related field).

• 5+ years of leadership or management experience, including direct supervision of teams.

• ASQ certification preferred (e.g., CQE, CMDA, CRE, CSSGB/CSSBB).

• Strong knowledge of IQ, OQ, PQ, and process capability studies.

• Expertise in FMEA, hazard analysis, control plans and post-market surveillance.

• Proficiency in Six Sigma, SPC, DOE, Gage R&R, and root cause analysis tools.

• Experience managing quality across multiple international manufacturing sites.

• Thorough understanding of industry regulations such as ISO 13485, FDA 21 CFR 820, ISO 14971, MDR, and other global regulatory requirements.

• Develop quality teams, provide technical coaching, and foster a culture of continuous improvement.

• Proficient in MS Office and Minitab or other statistical software.

• Lead quality transformations, process standardization, and organizational improvements.

• Strong analytical and critical thinking skills.

• Proficient in technical report writing and review.

• Strong verbal and written communication skills.

• Foster a positive culture of growth, collaboration, adaptability to change, and achievement.