Senior Metrology Compliance Specialist (GMP/CAPA)

Mentor Technical Group; Boston (MA); On-site; USD 100,000 - 118,000; Full time

Job summary

MTG CALIBRATIONS in Boston, MA seeks a Calibration Compliance Specialist III to support metrology activities in a regulated life sciences setting. You will ensure calibration records and standards are managed per FDA/EU requirements and site procedures, and collaborate with Quality and Metrology teams to resolve issues.

The role emphasizes cross-functional coordination, deviation investigations, change control, and CAPA implementation to maintain regulatory compliance and product quality.

Qualifications

• Bachelor degree or equivalent in engineering/science.
• Experience in GMP manufacturing environment.

Responsibilities

• Perform metrology activities in accordance with FDA/EU GMP GDP and site procedures.
• Review calibration records for accuracy and traceability.
• Lead or support change controls affecting calibration procedures, equipment, reference standards, or metrology processes.
• Draft and review incident reports, deviation reports, and other quality records; document event details, impact assessments and evidence.
• Coordinate with Quality, Metrology, and other teams to track actions to completion and support timely closure of quality records.
• Lead or support investigations of metrology-related quality events and perform root cause analysis.

Skills

Technical writing

Cross-functional coordination

Root cause analysis

CAPA processes

Education

Bachelor’s degree in engineering, science, or a related technical field

Tools

Deviation investigations

Change control

CAPA tracking

Job description

MTG CALIBRATIONS in Boston, MA seeks a Calibration Compliance Specialist III to support metrology activities in a regulated life sciences setting. You will ensure calibration records and standards are managed per FDA/EU requirements and site procedures, and collaborate with Quality and Metrology teams to resolve issues.

The role emphasizes cross-functional coordination, deviation investigations, change control, and CAPA implementation to maintain regulatory compliance and product quality.