Manager, Quality Engineering

About the Role

The Quality Engineering Manager provides strategic and operational leadership for the Quality Engineering, Calibration, and Inspection functions across multiple manufacturing sites producing medical device components and finished medical devices. This role partners with 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 manager leads a team of quality engineers, calibration specialists, inspectors, and quality team leads, fostering a culture of quality ownership, operational excellence, and customer focus while ensuring compliance with ISO 13485, FDA Quality System Regulation, and other regulatory requirements. This position actively engages 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.

Responsibilities

• 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.

Requirements

• Bachelor’s Degree in engineering or other quality-related technical field.
• Minimum 10 years of experience in Quality Management.
• Medical device manufacturing experience required.
• Multi-site leadership experience preferred.

Skills

• Expert knowledge of Quality Engineering principles and methodologies.
• Strong understanding of manufacturing processes and operational excellence principles.
• Demonstrated expertise in root cause analysis and corrective action systems.
• Experience leading scrap reduction, yield improvement, and COPQ reduction initiatives.
• Strong understanding of process risk management and quality planning methodologies.
• Working knowledge of:
  • ISO 13485
  • FDA 21 CFR Part 820
  • Risk Management (ISO 14971)
  • Process Validation
  • Statistical Process Control (SPC)
  • Design of Experiments (DOE)
  • Measurement System Analysis (MSA)
  • PFMEA and Control Plans
  • Lean Manufacturing
  • Six Sigma methodologies
  • Metrology and calibration systems
• Proficiency with Minitab, statistical software, ERP systems, and electronic quality systems.
• Excellent verbal, written, presentation, and interpersonal communication skills.
• Strong leadership and organizational capabilities with demonstrated success building high-performing teams.
• Ability to influence cross-functional stakeholders and drive organizational change.

Preferred Certifications

• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
• Six Sigma Black Belt or equivalent certification
• Certified Lead Auditor

Physical Demands

• Employee may be required to remain stationary for extended periods of time.
• Employee may occasionally be required to transverse through office and/or manufacturing locations.
• Employee will frequently be required to actively listen and exchange information.
• Employee will be required to observe and assess information received via computer.
• Requires use of computer, telephone, and operation of a motor vehicle.

Work Environment

• Estimated travel of 30%.
• Must have reliable, appropriate transportation.
• Job requires visitation to various Nordson and customer sites, which have varying environments/conditions, layouts, and accessibility.