Senior Quality Systems Engineer - Med Device - Boxford, MA

Michael Page; Andover (MA); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Competitive salary and bonus

Comprehensive benefits package

Opportunities for professional growth

Collaborative work environment

Job summary

A leading recruitment agency is seeking a Senior Quality Systems Engineer in Andover, MA. The candidate will drive compliance and continuous improvement in quality management systems. Key responsibilities include managing the CAPA program, conducting internal audits, and collaborating cross-functionally. The ideal candidate has experience in quality regulations and strong analytical skills, with a competitive salary and benefits offered.

Qualifications

• Strong experience managing CAPA programs and driving root cause investigations.
• Solid understanding of quality system regulations and standards (e.g., ISO 13485, FDA QSR).
• Proven ability to lead internal audits and support regulatory inspections.

Responsibilities

• Lead the Corrective and Preventive Action (CAPA) program, ensuring timely resolution.
• Manage internal audits and support external inspections.
• Monitor and report on key quality metrics.

Skills

Management of CAPA programs

Analytical skills

Organizational skills

Communication skills

Job description

Senior Quality Systems Engineer - Med Device - Boxford, MA

Base pay range: $110,000.00/yr - $130,000.00/yr

The Senior Quality Systems Engineer plays a key role in driving compliance and continuous improvement across the organization's quality management systems. This role leads the CAPA program, internal audits, and quality metrics, ensuring issues are resolved through structured problem-solving and cross-functional collaboration. This company is driving innovation in advanced medical technologies that support critical care and improve patient outcomes in a fast-paced, mission-driven environment.

Description

• Lead the Corrective and Preventive Action (CAPA) program, ensuring timely and effective resolution of quality issues.
• Manage internal audits and support external inspections to maintain compliance with regulatory standards.
• Monitor and report on key quality metrics, driving data-informed improvements.
• Collaborate cross-functionally to enhance quality system processes and documentation.
• Support continuous improvement initiatives across the organization’s quality management system.

Profile

• Strong experience managing CAPA programs and driving root cause investigations.
• Solid understanding of quality system regulations and standards (e.g., ISO 13485, FDA QSR).
• Proven ability to lead internal audits and support regulatory inspections.
• Excellent analytical, organizational, and communication skills.
• Experience in a regulated medical or life sciences environment preferred.

Job Offer

• Competitive salary and bonus.
• Comprehensive benefits package to support your well-being.
• Opportunities for professional growth and development within the engineering and manufacturing department.
• A collaborative work environment within the life science industry.

If you are ready to take your career to the next level, apply now to join a team dedicated to quality and innovation!

Legal and Equal Opportunity Statement

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.

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing

Note: This description consolidates key responsibilities, qualifications, and benefits for the Senior Quality Systems Engineer role. Other postings and lists observed in the source have been removed to maintain clarity.