Senior Calibration Technician – GMP/ISO

Integra LifeSciences Corporation

Braintree (MA)

On-site

USD 36,000 - 49,000

Full time

13 days ago

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Job summary

Integra LifeSciences Corporation in US-MA-Braintree is seeking a Quality Calibration Technician II to lead the site calibration program in compliance with ISO 13485 and GMP. You will manage calibration schedules, ensure traceability to NIST standards, and support audits and CAPA across facilities, quality, manufacturing, and engineering teams.

The role emphasizes risk-based calibration, documentation discipline, and collaboration with external service providers to minimize downtime while

Qualifications

  • HS diploma or equivalent with at least 3 years in calibration or metrology.
  • 3+ years calibration experience in regulated pharma/medical device environment.
  • Experience with ISO 17025 accredited calibration service providers.
  • Knowledge of QMSR, ISO 13485, and 21 CFR Part 11.
  • Experience coordinating external calibration providers.
  • Strong communication and cross-functional collaboration.
  • Ability to work in a fast-paced, cross-functional team.

Responsibilities

  • Calibration Program Management.
  • Maintain calibration records, schedules and certificates using Blue Mountain RAM.
  • Prevent overdue calibrations and lock out past due equipment.
  • Coordinate calibration activities with external service providers to minimize disruption.
  • Ensure all calibrations are traceable to NIST or equivalent standards and meet accuracy requirements.
  • Classify instruments by criticality and apply risk-based calibration strategy.
  • Documentation and Compliance: maintain audit-ready calibration records.
  • Support nonconformances, CAPA and investigations related to calibration.
  • Cross-functional collaboration with Facilities, Quality Assurance, Manufacturing, Engineering, and Validation.

Skills

Calibration
Metrology
ISO 13485
CAPA

Education

High school diploma

Tools

Blue Mountain RAM

Job description

Integra LifeSciences Corporation in US-MA-Braintree is seeking a Quality Calibration Technician II to lead the site calibration program in compliance with ISO 13485 and GMP. You will manage calibration schedules, ensure traceability to NIST standards, and support audits and CAPA across facilities, quality, manufacturing, and engineering teams.

The role emphasizes risk-based calibration, documentation discipline, and collaboration with external service providers to minimize downtime while

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