Quality Manager — Medical Devices QMS Leader

CONSOLIDATED STERLIZER SYSTEMS; Billerica (MA); On-site; USD 135,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Vision coverage

401(k) with company match

Paid time off

Job summary

Consolidated Sterilizer Systems, a leading steam sterilization systems manufacturer, seeks a Quality Manager to ensure products meet medical device regulations and customer specs. You will lead a small QA/QC team, drive CAPA/NCR processes, and partner with cross-functional groups to uphold the quality system.

The role combines strategic leadership with hands-on involvement in day-to-day operations, including audits, document control, and continuous improvement initiatives.

Qualifications

• Minimum of a technical degree in engineering or related field.
• 5+ years in manufacturing with quality management and control experience.
• Experience with FDA medical device regulations and GMP/QSR.
• Proficiency with Electronic Quality Management Systems.

Responsibilities

• Lead and improve the Quality Management System.
• Ensure products meet customer, technical, and regulatory specs.
• Manage QA/QC team, audits, NCR, CAPA, and supplier quality.
• Coordinate with cross-functional teams on quality initiatives.
• Serve as Management Representative for regulatory bodies.

Skills

Quality management

Leadership

Data analysis

Regulatory compliance

Process improvement

Audit leadership

Cross-functional collaboration

Education

Engineering degree

Tools

Electronic Quality Management Systems

ASME codes & standards

Job description

Consolidated Sterilizer Systems, a leading steam sterilization systems manufacturer, seeks a Quality Manager to ensure products meet medical device regulations and customer specs. You will lead a small QA/QC team, drive CAPA/NCR processes, and partner with cross-functional groups to uphold the quality system.

The role combines strategic leadership with hands-on involvement in day-to-day operations, including audits, document control, and continuous improvement initiatives.