Quality Calibration Technician II

Integra LifeSciences • Braintree, MA

3d • $26 - $35

About The Position

The Quality Calibration Technician II reviews, manages, and maintains the site calibration program in compliance with ISO 13485, GMP requirements, internal and external regulations, QMSR, and 21 CFR Part 11. The role ensures instruments and equipment subject to calibration are identified, scheduled, calibrated within defined intervals, and maintained in a compliant, audit-ready state. It works cross-functionally with Facilities, Quality, Manufacturing, Engineering, and Validation to support operations, nonconformance investigations, and continuous improvement.

The technician manages the calibration program using Blue Mountain RAM, maintains calibration records and schedules, coordinates external providers, and ensures calibration traceability to NIST or equivalent national standards. The role also reviews certificates, supports equipment onboarding and decommissioning, participates in out-of-tolerance investigations and CAPA activities, and serves as a subject matter expert during audits and inspections.

The position is based in a recently built facility, with a primary workspace spanning office and regulated manufacturing floor environments. The employee may access manufacturing, laboratory, equipment, cleanroom, and refrigerated or frozen storage areas. Cleanroom dress code and PPE apply in controlled manufacturing areas. Potential exposures include hazardous and biohazardous materials, such as flammable and corrosive liquids, compressed gases, sharps, and medical waste. Physical duties include occasional lifting up to 20 pounds, frequent walking, occasional to frequent standing, and occasional stair use, stooping, and kneeling.

Requirements

• High school education or equivalent; a minimum of high school education is required.
• At least 3 years of applicable experience.
• At least 3 years of calibration or metrology experience in a regulated pharmaceutical or medical device environment.
• Experience with ISO 17025-accredited calibration service providers.
• Working knowledge of QMSR, ISO 13485, and 21 CFR Part 11.
• Experience coordinating external calibration service providers and reviewing calibration certificates.
• Working knowledge of out-of-tolerance handling and CAPA processes.
• Experience supporting product impact assessments for out-of-tolerance conditions.
• Effective written and oral communication skills.
• Demonstrated ability to work cross-functionally in a team environment.
• Ability to meet the stated physical and sensory requirements, including occasional lifting up to 20 pounds, frequent walking, regular manual dexterity, and required vision, hearing, and communication abilities.

Responsibilities

• Maintain and manage the site calibration program in Blue Mountain RAM, including instrument identification, calibration intervals, schedules, records, and certificates.
• Monitor calibration schedules and segregate or lock out equipment that is past due or found out of calibration.
• Coordinate calibration activities with external service providers to minimize disruption to manufacturing operations.
• Ensure calibrations are traceable to NIST or equivalent national standards and meet defined measurement uncertainty and accuracy requirements.
• Classify instruments by criticality and apply risk-based calibration frequencies and acceptance criteria.
• Maintain complete, compliant, audit-ready calibration records, including certificates, asset histories, and out-of-tolerance reports, in accordance with GDP and ALCOA+ principles.
• Review and approve calibration certificates for accuracy, acceptance criteria, and traceability within required timelines.
• Notify management and Quality Assurance of out-of-calibration conditions and support product impact assessments and investigations.
• Provide calibration records, asset history, and technical data for investigations; support root cause analysis, CAPA, and deviation documentation.
• Coordinate with Supplier Quality on qualification and approval of external calibration providers and review vendor certificates and service agreements.
• Support onboarding of new equipment, including asset creation, initial calibration, and verification of calibration and traceability requirements.
• Support decommissioning of obsolete equipment and ensure critical process equipment meets accuracy requirements and remains in a validated state.
• Serve as the calibration program subject matter expert during internal, external, FDA, ISO, and customer audits and inspections.
• Address audit findings related to calibration within required timelines and ensure records are complete, traceable, and readily retrievable.
• Collaborate with Facilities, Quality Assurance, Manufacturing, Engineering, and Validation teams to coordinate calibration and support operational needs.
• Participate in calibration interval optimization, process improvements, digital system enhancements, and change control activities.
• Ensure changes to calibration intervals, tolerances, instruments, or methods follow formal change control, including risk assessment and QA approval as required.
• Perform other Quality Systems-related duties as required.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• 401(k) savings plan
• Employees may be eligible for bonus, commission, equity, or other variable compensation, subject to applicable terms.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED