Quality Calibration Tech II: Precision in Pharma

Integra LifeSciences; Braintree (MA); On-site; USD 36,000 - 49,000; Full time

Job summary

Integra LifeSciences is seeking a Quality Calibration Technician II to manage the site calibration program in a regulated environment. You will ensure instruments are calibrated on schedule, traceable to national standards, and maintained in audit-ready condition.

You will collaborate across Facilities, Quality, Manufacturing, Engineering, and Validation to optimize calibration frequencies, address deviations, and support CAPA activities. A strong emphasis on GDP/ALCOA+ is included.

Qualifications

• Minimum of high school education 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.
• Experience supporting CAPA processes and product impact assessments.

Responsibilities

• Maintain and manage the calibration program using Blue Mountain RAM.
• Serve as the responsible person for calibration program content and records.
• Monitor schedules to prevent overdue calibrations and lock out overdue equipment.
• Coordinate calibration activities with external service providers.
• Ensure calibrations are traceable to NIST or equivalent standards.
• Classify instruments by criticality and adjust frequency and acceptance criteria.
• Support audit readiness and respond to inquiries with complete records.
• Collaborate cross-functionally with Facilities, Quality, Manufacturing, Engineering, and Validation.

Skills

Calibration experience

Regulatory compliance

Cross-functional collaboration

Effective communication

Education

High school diploma

Tools

Blue Mountain RAM

Job description

Integra LifeSciences is seeking a Quality Calibration Technician II to manage the site calibration program in a regulated environment. You will ensure instruments are calibrated on schedule, traceable to national standards, and maintained in audit-ready condition.

You will collaborate across Facilities, Quality, Manufacturing, Engineering, and Validation to optimize calibration frequencies, address deviations, and support CAPA activities. A strong emphasis on GDP/ALCOA+ is included.