Mitsubishi Chemical America · 3 hours ago
Quality Manager
Wilmington, MA
Full-time
Onsite
Mid, Senior Level
$88K/yr - $110K/yr
5+ years expMitsubishi Chemical America is seeking an experienced Quality Manager to lead and continuously improve their Quality Management System in a regulated manufacturing environment. This role is critical for ensuring product quality, regulatory compliance, and operational excellence, overseeing daily quality operations and collaborating with various teams.
3D PrintingChemicalIndustrialManufacturing
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
Qualification
Required
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
Company
Mitsubishi Chemical America
Mitsubishi Chemical America is a manufacturer of thermoplastic materials in the form of semi-finished products and finished parts.
1001-5000 employees
H1B Sponsorship
Mitsubishi Chemical America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Randy Queen
President & CEO
Junell Coleman
Human Resource Business Partner
Recent News
2025-08-05
2025-08-05
Company data provided by crunchbase