Quality Manager

Mitsubishi Chemical Group • Wilmington, MA

50d • $87,800 - $109,800

About The Position

We are seeking an experienced Quality Manager to lead and continuously improve our Quality Management System in a regulated manufacturing environment. This role plays a critical part in ensuring product quality, regulatory compliance, and operational excellence across the site. The Quality Manager oversees daily quality operations, including product and raw material release, batch record review, investigations, audits, CAPA, validation, and training. This position also serves as the ISO Management Representative and partners closely with Manufacturing, Engineering, and Regulatory teams.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a technical discipline
• Equivalent experience (10+ years) will be considered in lieu of a degree
• 5+ years of Quality experience in a medical device, pharmaceutical, or biotechnology manufacturing environment
• 3+ years of leadership experience
• Strong knowledge of cGMP regulations, quality systems, and validation requirements
• Proven experience supporting FDA inspections and third-party audits
• Excellent written and verbal communication skills
• Ability to work independently, manage multiple priorities, and lead projects in a fast-paced environment
• Demonstrated team player with experience collaborating across multidisciplinary teams

Responsibilities

• Lead daily quality activities including batch record review and approval, commercial product release, and raw material release
• Own and maintain the Quality Management System (QMS), including audits, change control, material control, investigations, CAPA, and quality policies
• Write, review, approve, and implement quality SOPs and policies
• Review manufacturing and QC documentation to ensure compliance prior to final product release
• Lead and support internal, external, and third-party audits, including regulatory inspections by the FDA
• Serve as the ISO Management Representative, ensuring audit readiness and certification compliance
• Support qualification and validation activities for processes, equipment, and systems
• Design and implement training programs to promote quality awareness and compliance
• Act as a key quality partner to cross-functional teams and drive continuous improvement initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Manager