Quality Calibration Technician II

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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 remains within a validated state.

Audit And Inspection Support Act as Subject Matter Expert (SME) for the calibration program during internal, external, FDA, ISO, and customer audits and inspections.

Ensure calibration records are complete, traceable, and immediately retrievable to support audit inquiries.

Address audit findings related to calibration within defined procedural timelines.

Demonstrate no gaps in calibration history and proper handling of deviations during audit and inspection activities.

Cross-Functional Collaboration Work cross-functionally with Facilities, Quality Assurance, Manufacturing, Engineering, and Validation teams to coordinate calibration activities and support daily operational needs.

Participate in calibration interval optimization, process improvements, and digital system enhancements.

Support change control activities for equipment, procedures, and software systems in accordance with applicable quality system procedures.

Ensure any changes to calibration intervals, tolerances, instruments, or methods are processed through formal change control, including risk assessment and QA approval as required.

QUALIFICATIONS

• A minimum of high school education is required with 3 years applicable experience
• 3+ years of calibration, metrology, experience in a regulated pharma 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
• Ability to communicate effectively both written and oral
• Demonstrated ability to work cross-functionally in a team environment
• The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position.
• WORKING CONDITIONS
• Temperature: Controlled indoor environment within a recently built facility. The Quality Calibration Technician may be exposed to varying temperature environments when accessing manufacturing areas, including cleanroom environments and refrigerated or frozen storage areas.
• Noise Level: Consistent with a professional office environment. Noise levels increase when accessing manufacturing and laboratory areas, generated by processing and manufacturing equipment.
• Lighting: Artificial lighting throughout office and manufacturing areas.
• Air Quality: Controlled ventilation and HVAC systems throughout office and manufacturing areas. Cleanroom environment with additional air quality controls applies when accessing regulated manufacturing areas.
• Workspace: Primary workspace includes both office and regulated manufacturing floor environments within a recently built facility. The Quality Calibration Technician will access manufacturing, laboratory, and equipment areas as required to support calibration program activities. Cleanroom dress code and PPE requirements apply when in controlled manufacturing areas.
• Adverse Working Conditions: Adverse exposure may result from the handling of hazardous and biohazardous materials, including flammable and corrosive liquids, compressed gases, sharps, and medical waste, when accessing manufacturing areas. All handling procedures shall comply with applicable safety procedures and regulations.
• PHYSICAL REQUIREMENTS
• Strength Requirements: The associate may have to lift up to 20 lbs. occasionally, 10 lbs. frequently.
• Mobility Requirements: Standing: Occasional to frequent, as required when accessing manufacturing, laboratory, and equipment areas
• Walking: Frequent movement throughout the facility, including office, manufacturing, laboratory, and equipment areas as required
• Sitting: Moderate to frequent; primary administrative and documentation work is performed at a desk or workstation
• Climbing: Occasional use of stairs as required within the facility
• Stooping/Crouching: Occasional, as required when accessing equipment for calibration activities
• Kneeling: Occasional, as required when accessing equipment for calibration activities
• Manual Dexterity: Regular use of hands for computer operation, handling calibration equipment, and documentation
• Sensory Requirements: Vision: Close vision and ability to adjust focus required for computer work, review of calibration certificates, and reading measurement instrumentation. Color vision, peripheral vision, and depth perception required when accessing manufacturing areas.
• Hearing: Ability to communicate effectively in both office and manufacturing environments and to auditory safety signals.
• Speaking: Ability to communicate clearly with team members, cross-functional departments, vendors, and management.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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