Sr. Quality Manager

Sr Quality Manager

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

Sr Quality Manager Duties :

• Oversee and maintain 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

A successful Sr. Quality Manager should have :

What's on Offer

What is on offer :

Job summary :

Sector : Engineering & Manufacturing

Sub Sector : Quality, Technical

Industry : Industrial / Manufacturing

Location : Danvers

Contract Type : Permanent

Consultant name : Bridget Petti

Job Reference : JN-102025-6868918