Quality Calibration Technician II

## Quality Calibration Technician IIApply:
US-MA-Braintree-220-Facility:
Full time:
Posted Today:
JR-6784

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
** SUMMARY
* * The Quality Calibration Technician II is responsible for reviewing, managing and maintaining the site calibration program in compliance with ISO 13485, GMP requirements, internal and external regulations. This role ensures that all instruments and equipment subject to calibration are identified, scheduled, calibrated within defined intervals, and maintained in a compliant and audit-ready state. The Quality Calibration Technician II works cross-functionally with Facilities, Quality, Manufacturing, Engineering, and Validation teams to support daily operations, non-conformance investigations, and continuous improvement of the calibration program.

All activities are performed in compliance with QMSR, ISO 13485, 21 CFR Part 11, and applicable Good Documentation Practices.  
** ESSENTIAL DUTIES AND RESPONSIBILITIES
*** Calibration Program Management  + Maintain and manage the site calibration program using Blue Mountain RAM to ensure all instruments are identified, assigned calibration intervals, and scheduled for calibration within defined procedural timelines.  + Serve as the responsible person for calibration program content within Blue Mountain RAM, including maintenance of calibration records, schedules, and certificates, in coordination with IT as system owner.  

+ Monitor calibration schedules to prevent overdue calibrations; segregate or lock out any equipment past due for calibration in accordance with applicable procedures.  + Coordinate calibration activities with external calibration service providers to ensure minimal disruption to manufacturing operations.  + Ensure all calibrations are traceable to NIST or equivalent national standards and meet defined measurement uncertainty and accuracy requirements.  + Classify instruments by criticality based on product quality and safety impact and apply a risk-based calibration strategy to adjust calibration frequency and acceptance criteria accordingly.
* Documentation And Compliance  + Maintain complete, compliant, and audit-ready calibration records including calibration certificates, asset history, and out-of-tolerance reports in accordance with GDP and ALCOA+ principles.  + Ensure compliance with QMSR, ISO 13485, 21 CFR Part 11, and internal SOPs at all times.  + Review and approve calibration certificates for accuracy, acceptance criteria, and traceability to NIST or equivalent standards within defined procedural timelines.  

+ Ensure no gaps in calibration history and proper handling and documentation of all deviations.  + Perform other Quality Systems-related duties as required.
* Nonconformances and CAPA Support  + Identify and flag instruments found out of calibration; segregate or lock out affected equipment promptly and within required timelines.  + Notify management and Quality Assurance of out-of-calibration conditions within defined procedural timelines.  + Support product impact assessments for nonconformance conditions.  + Provide calibration records, asset history, and technical data to support investigations as requested.  + Support root cause analysis and CAPA activities related to calibration issues as assigned by management.  

+ Support deviation and CAPA documentation in accordance with applicable quality system procedures.
* Vendor And Equipment Lifecycle Management  + Coordinate with the Supplier Quality function for the qualification and approval of external calibration service providers; ensure vendors maintain ISO 17025 accreditation or equivalent.  + Review vendor calibration certificates and service agreements to ensure compliance with applicable requirements.  + Support set up of new equipment onboarding with documentation provided by Process Engineering: including asset creation, initial calibration, and verification that new instruments meet calibration and traceability requirements.  

+ Support decommissioning of obsolete equipment in accordance with applicable procedures.  + Ensure all critical process equipment meets defined accuracy requirements and…