Audit-Ready Calibration Technician II

Integra LifeSciences Corporation

Braintree (MA)

On-site

USD 36,000 - 49,000

Full time

3 days ago

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Job summary

Integra LifeSciences Corporation is seeking a Quality Calibration Technician II to manage and improve the site calibration program in a regulated medical device environment. You will ensure calibrations are traceable to recognized standards, maintain audit-ready records, and support CAPA initiatives across Facilities, Quality, and Manufacturing.

The role requires hands-on calibration experience, knowledge of QMSR/ISO13485 and 21 CFR Part 11, and strong collaboration across cross-functional teams

Qualifications

Minimum of high school education with 3 years of calibration/metrology experience.
Experience with ISO 17025 accredited calibration service providers.
Working knowledge of QMSR, ISO 13485, and 21 CFR Part 11.
Experience coordinating external calibration services and reviewing certificates.

Responsibilities

Maintain and manage the site calibration program using Blue Mountain RAM and schedule calibrations within defined timelines.
Ensure calibration records are complete, traceable to standards, and audit-ready.
Support nonconformances, CAPA, and root-cause analyses related to calibration issues.
Coordinate with Facilities, Quality, Manufacturing, Engineering and Validation teams to optimize calibration intervals.

Skills

Calibration

Metrology

ISO 17025

QMSR

CAPA

Audit support

Cross-functional

Documentation

Education

High school diploma

Tools

Blue Mountain RAM

Job description

The role requires hands-on calibration experience, knowledge of QMSR/ISO13485 and 21 CFR Part 11, and strong collaboration across cross-functional teams

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