Senior Med Device Quality Systems Lead: CAPA & Audits

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

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.