The Manager, Manufacturing Quality is responsible for leading Quality Assurance and supporting commercial Metals Manufacturing operations. This role provides leadership and oversight for inspection, testing, nonconformance management, product disposition, quality data review, and compliance activities to ensure product quality, operational excellence, and regulatory compliance. The position partners closely with Manufacturing, Engineering, Supply Chain, and Quality stakeholders to drive timely resolution of quality issues and continuous improvement across commercial production operations.
How You Will Make An Impact:- Lead Quality Assurance activities and support commercial Metals Manufacturing operations, ensuring compliance with quality system requirements and regulatory standards.
- Direct and develop a team of quality supervisors, inspectors, and quality professionals to support manufacturing operations, product inspection, testing, and release activities.
- Provide leadership and oversight for nonconformance investigations (NCRs), ensuring timely evaluation, containment, disposition, root cause investigation, and closure.
- Establish and maintain quality inspection and testing strategies for in-process and finished products to ensure compliance with product specifications and quality requirements.
- Partner with Manufacturing, Engineering, Supply Chain, and Quality Engineering teams to resolve quality issues, support production objectives, and drive continuous improvement initiatives.
- Oversee product quality disposition activities, including product holds, release decisions, and escalation of quality risks when appropriate.
- Monitor and analyze quality performance metrics and operational trends, providing data-driven recommendations to improve product quality, compliance, and manufacturing performance.
- Ensure inspection processes, testing activities, and quality documentation comply with internal procedures and applicable regulatory requirements.
- Support internal and external audits, regulatory inspections, and management reviews through preparation, execution, and follow-up activities.
- Develop team capabilities through coaching, performance management, succession planning, and technical skill development.
- Identify and implement process improvements to enhance efficiency, effectiveness, and compliance within the Quality Assurance organization.
What You'll Need (Required):- Bachelor's degree in engineering or scientific disciplines
- Experience within Quality Assurance, Quality Engineering, Manufacturing Quality, or Operations Quality in Medical Device manufacturing; or equivalent experience based on Edwards' criteria.
- Experience directly leading people, including supervisors, inspectors, technicians, and/or professionals.
What Else We Look For (Preferred):- Engineering or Science degree
- Medical device manufacturing experience.
- Experience leading Quality Assurance teams supporting commercial manufacturing operations.
- Experience with nonconformance management (NCRs), product disposition, initiating and removing product holds, quality investigations, and root cause analysis.
- Experience overseeing incoming, in-process, and finished goods inspection and testing activities.
- Strong knowledge of FDA Quality System Regulation, ISO 13485, and Good Manufacturing Practices (GMP) as they relate to product realization and manufacturing.
- Experience supporting audit readiness, regulatory inspections, and quality management reviews.
- Working knowledge of statistical quality methods, quality metrics, and trend analysis.
- Experience driving continuous improvement initiatives utilizing Lean, Six Sigma, or similar methodologies.
- Experience using quality management systems and enterprise systems such as ETQ, JDE, PLM, SAP, or similar platforms.
- ASQ CQE or other ASQ quality certifications.
