Michael Page
Senior Quality Manager - Medical - Danvers, MA
Michael Page, Danvers, Massachusetts, us, 01923
Senior Quality Manager - Medical - Danvers, MA
Base pay range: $165,000 - $195,000 per year.
Description Lead quality strategy and execution across product development and manufacturing, ensuring compliance with regulatory standards and internal quality systems. The role drives continuous improvement, oversees risk management and audits, and collaborates cross‑functionally to support operational excellence and product integrity.
Lead the development, implementation, and continuous improvement of quality systems and processes across product development and manufacturing operations.
Ensure compliance with global regulatory standards and internal quality requirements, including oversight of audits, CAPAs, and risk management activities.
Collaborate cross‑functionally to support design control, process validation, and design transfer, ensuring quality integration throughout the product life cycle.
Monitor production processes using data‑driven methodologies to identify trends, deviations, and opportunities for improvement.
Oversee supplier quality programs, including qualification, audits, and incoming material inspections to ensure consistent product standards.
Drive strategic quality initiatives, mentor team members, and foster a culture of accountability, innovation, and operational excellence.
Support regulatory inspections and customer audits, ensuring readiness and effective communication of quality system performance.
Utilize project management tools to balance competing priorities and deliver high‑impact quality outcomes.
Profile
Bachelor's degree in engineering, life sciences, or a related technical field; advanced degree preferred.
8+ years of experience in quality assurance or quality engineering within a regulated industry, ideally medical technology or life sciences.
Proven leadership experience managing quality teams and driving cross‑functional collaboration.
Deep understanding of quality systems, regulatory standards (ISO 13485, FDA 21 CFR Part 820), and risk management practices.
Strong background in design control, process validation, and product life cycle management.
Experience with supplier quality management, audits, CAPA, and continuous improvement methodologies.
Excellent analytical, communication, and project management skills, with the ability to influence and lead across functions.
Comfortable working in a fast‑paced, evolving environment with a focus on operational excellence and innovation.
Job Offer
Competitive salary and bonus potential.
Opportunity to work within a growing company in the life science industry.
Comprehensive benefits package and potential for career advancement.
Collaborative work environment focused on innovation and excellence.
Take the next step in your career as a Senior Manager of Quality by applying today!
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.
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Description Lead quality strategy and execution across product development and manufacturing, ensuring compliance with regulatory standards and internal quality systems. The role drives continuous improvement, oversees risk management and audits, and collaborates cross‑functionally to support operational excellence and product integrity.
Lead the development, implementation, and continuous improvement of quality systems and processes across product development and manufacturing operations.
Ensure compliance with global regulatory standards and internal quality requirements, including oversight of audits, CAPAs, and risk management activities.
Collaborate cross‑functionally to support design control, process validation, and design transfer, ensuring quality integration throughout the product life cycle.
Monitor production processes using data‑driven methodologies to identify trends, deviations, and opportunities for improvement.
Oversee supplier quality programs, including qualification, audits, and incoming material inspections to ensure consistent product standards.
Drive strategic quality initiatives, mentor team members, and foster a culture of accountability, innovation, and operational excellence.
Support regulatory inspections and customer audits, ensuring readiness and effective communication of quality system performance.
Utilize project management tools to balance competing priorities and deliver high‑impact quality outcomes.
Profile
Bachelor's degree in engineering, life sciences, or a related technical field; advanced degree preferred.
8+ years of experience in quality assurance or quality engineering within a regulated industry, ideally medical technology or life sciences.
Proven leadership experience managing quality teams and driving cross‑functional collaboration.
Deep understanding of quality systems, regulatory standards (ISO 13485, FDA 21 CFR Part 820), and risk management practices.
Strong background in design control, process validation, and product life cycle management.
Experience with supplier quality management, audits, CAPA, and continuous improvement methodologies.
Excellent analytical, communication, and project management skills, with the ability to influence and lead across functions.
Comfortable working in a fast‑paced, evolving environment with a focus on operational excellence and innovation.
Job Offer
Competitive salary and bonus potential.
Opportunity to work within a growing company in the life science industry.
Comprehensive benefits package and potential for career advancement.
Collaborative work environment focused on innovation and excellence.
Take the next step in your career as a Senior Manager of Quality by applying today!
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.
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