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Company:

Mitsubishi Performance Polymers Division

Job Description:

About the Role

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.

Key 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

Qualifications

+ 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

Why This Role Is Attractive

+ **True Quality Leadership:** This role owns the site-level Quality Management System and serves as theISO Management Representative, giving you real influence over quality strategy and decision-making.

+ **High Visibility & Impact:** You’ll be a key partner to Manufacturing, Engineering, and Regulatory teams, directly impacting product quality, compliance, and patient safety.

+ **Regulatory Exposure:** Hands-on involvement with audits and inspections, including interactions with the FDA, provides valuable career-building experience.

+ **Broad Scope:** From product and raw material release to CAPA, validation, training, and audits, this role offers variety and depth for experienced Quality professionals.

+ **Continuous Improvement Focus:** The position goes beyond maintenance—there’s opportunity to strengthen systems, modernize processes, and leave a lasting impact.

•The salary range for this position is $87,800-$109,800. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

Applicants with disabilities may be entitled to a reasonable accommodation under the Americans with Disabilities Act and/or other applicable laws. If you require accommodation due to a disability at any time during the recruitment and/or assessment process, please contact Talent Acquisition.