Sr. Quality Manager - Medical Device - Danvers, MA

Sr Quality Manager Medical Device Danvers Ma

The company is a regulated medical device manufacturer committed to delivering high-quality, safe, and innovative products that meet global healthcare standards. With a strong focus on compliance, it operates under ISO 13485 and other international regulations to ensure excellence in product development, manufacturing, and quality systems.

Job Description

The role involves overseeing and maintaining the company's Quality Management System (QMS), ensuring compliance with medical device regulations including FDA 21 CFR 820, ISO 13485, and EU MDR. Lead internal and external audits, including FDA and Notified Body inspections, and manage audit readiness across departments. Supervise final product release processes, non-conformance investigations, and complaint handling to ensure product safety and regulatory compliance. Drive Corrective and Preventive Action (CAPA) programs, change control, and validation activities for processes, equipment, and methods. Analyze and report on Quality Indicators and KPIs, recommending improvements based on data trends and root cause analysis. Develop and mentor the Quality Assurance and Technical Investigations Group (TIG), fostering a culture of continuous improvement and regulatory excellence.

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.

The Successful Applicant

The ideal candidate will have a Bachelor's degree in a relevant scientific or engineering discipline. Minimum of 3-5 years of Quality Management experience in a regulated medical device manufacturing environment. Prior experience conducting internal or external audits; auditor certification is preferred. Working knowledge of global medical device regulations including FDA 21 CFR 820, ISO 13485, EU MDR, and other international standards. Formal training or certification in quality tools such as Six Sigma, CQE / CQA, FMEA, Root Cause Analysis, and validation methodologies is highly desirable.

What's on Offer

Competitive base salary. Comprehensive benefits package to support your well-being. Opportunities for professional growth and career advancement. An engaging work environment within the business services industry. Chance to make a significant impact on quality assurance initiatives.