Quality Manager; Mitsubishi Chemical Advanced Materials

Quality Manager

Are you a quality-driven leader passionate about continuous improvement, customer satisfaction, and operational excellence? We are seeking an experienced Quality Manager to lead the Quality function at our Fort Wayne facility and drive a culture focused on compliance, accountability, and continuous improvement.

This role is responsible for managing the site Quality Management System, ensuring compliance with regulatory and customer requirements, leading quality improvement initiatives, and serving as the key quality contact for customers, audits, and cross-functional operations support.

• Lead and maintain the site Quality Management System (QMS) to ensure compliance with ISO 9001, ISO 13485, ISO 17025, and customer requirements
• Serve as the primary contact for third-party audits and customer quality audits
• Manage local audit programs including scheduling, training, reporting, and corrective action follow-up
• Support compliance activities related to product standards and regulatory requirements

• Establish and monitor quality KPIs, analyze trends, and report on overall system effectiveness
• Lead root cause analysis, CAPA initiatives, and continuous improvement projects
• Support deployment of Lean Six Sigma and continuous improvement methodologies across the site
• Utilize data-driven decision-making tools to improve quality performance and operational efficiency

• Serve as the primary quality contact for customer concerns, audits, site visits, complaints, and returns
• Ensure timely communication and resolution of customer quality issues
• Collaborate cross-functionally to troubleshoot and resolve quality concerns
• Support validation processes and customer notifications as required

• Manage and develop the Quality team including staffing, scheduling, training, coaching, and performance management
• Promote quality awareness and provide training in auditing, quality systems, and problem-solving methodologies
• Foster strong collaboration across departments to support plant and customer objectives
• Lead selected Americas quality initiatives and projects requiring cross-functional influence and coordination

• Bachelor's degree in Engineering, Business, or related field
• 3–10 years of quality management experience in a manufacturing environment
• 2–5 years of supervisory or team leadership experience
• Strong knowledge of Quality Management Systems and ISO standards including ISO 9001 and ISO 13485
• Experience with Root Cause Analysis, CAPA, SPC, Lean Six Sigma, and continuous improvement methodologies
• ASQ certifications such as CQA, CQM, CQE, or Lead Auditor certifications preferred
• Lean Six Sigma Black Belt certification preferred
• Experience with eQMS platforms preferred
• Strong communication, organizational, and problem-solving skills
• Ability to influence cross-functional teams and manage multiple priorities in a fast-paced environment
• Proficiency with Microsoft Office, MRP systems, and Minitab
• Ability to travel up to 25%, including occasional international travel

• Lead quality initiatives in a dynamic manufacturing environment
• Influence operational excellence and customer satisfaction across the organization
• Opportunity to drive meaningful process improvements and quality system enhancements
• Collaborate with cross-functional leadership teams across North America
• Competitive compensation and comprehensive benefits package