Manager, Quality Engineering

General Summary

The Quality Engineering Manager is responsible for providing strategic and operational leadership for the Quality Engineering, Calibration, and Inspection functions across multiple manufacturing sites that produce both medical device components and finished medical devices. This role serves as a key partner to operations, manufacturing engineering, supply chain, and regulatory/quality systems leadership to improve product quality, reduce Cost of Poor Quality (COPQ), drive process capability, and ensure compliance with applicable regulatory and quality system requirements.

The Quality Engineering Manager leads a team of quality engineers, calibration specialists, inspectors, and quality team leads, ensuring effective support of manufacturing operations through risk-based decision making, statistical analysis, root cause investigations, and continuous improvement initiatives. The manager establishes a culture of quality ownership, operational excellence, and customer focus while ensuring compliance with ISO 13485, FDA Quality System Regulation, and other applicable regulatory requirements.

This position is expected to actively engage with manufacturing operations to identify process risks, reduce scrap and rework, improve yield, and eliminate recurring quality issues through structured problem-solving and data-driven decision making.

• Lead and develop quality engineering teams across multiple manufacturing locations.
• Establish priorities and allocate quality engineering resources to support business objectives, customer requirements, and production needs.
• Provide technical leadership in quality engineering disciplines including process validation, risk management, statistical analysis, product quality, process quality, and continuous improvement.
• Develop team capabilities through coaching, mentorship, training, and succession planning while promoting a culture of accountability, collaboration, inclusion, learning, and continuous improvement.
• Lead quality investigations, nonconformance reviews, CAPA activities, and complaint-related investigations as assigned.
• Ensure quality records are maintained in accordance with applicable Good Documentation Practices (GDP).
• Serve as a strategic partner to Operations leaders to improve manufacturing performance, product quality, delivery performance, and operational efficiency.
• Drive understanding of process risk throughout the organization utilizing risk management tools such as PFMEA, process controls, control plans, and statistical monitoring techniques.
• Ensure Quality Engineering resources are appropriately embedded within manufacturing operations to support production, quality issues, investigations, and process improvements.
• Support manufacturing readiness for new product introductions, process transfers, and capacity expansion initiatives.
• Provide technical guidance during production escalations and significant quality events.
• Lead site and division-level initiatives focused on Cost of Poor Quality (COPQ) reduction.
• Champion data-driven approaches to identify quality losses, scrap drivers, rework trends, and process inefficiencies.
• Ensure corrective and preventive actions address systemic causes and achieve sustainable improvements.
• Utilize quality metrics and trend analysis to identify improvement opportunities throughout the value stream.
• Provide leadership and oversight of calibration programs across multiple sites.
• Ensure all inspection, measurement, and test equipment is maintained, calibrated, and compliant with regulatory requirements.
• Ensure calibration systems support manufacturing, validation, and product acceptance activities.
• Oversee compliance with applicable metrology standards and measurement system requirements.
• Serve as a quality representative during customer interactions related to product quality, investigations, audits, and technical support.
• Support supplier quality initiatives as required.
• Collaborate with customers and cross-functional teams to address quality concerns and enhance customer satisfaction.
• Promote data-driven decision making throughout quality and manufacturing operations.
• Utilize statistical methods and software tools to evaluate process performance and identify opportunities for improvement.
• Develop and maintain appropriate quality metrics to ensure standard and regulatory compliance as well as drive continuous improvement and efficiency in the overall production operation.
• Drive Lean and Six Sigma initiatives focused on reducing waste, improving process capability, and increasing operational performance.

To perform this position successfully, an individual must be able to perform each job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

• Bachelor’s Degree in engineering or other quality related…