Senior Calibration Technician II — ISO 13485/GMP Compliance

TEI BIOSCIENCES INC; Braintree (MA); On-site; USD 36,000 - 49,000; Full time

Job summary

TEI BIOSCIENCES INC is seeking a Quality Calibration Technician II to manage the site calibration program in accordance with ISO 13485 and GMP standards. You will identify instruments, schedule calibrations, maintain records, and ensure audit-ready documentation while partnering with Facilities, Quality, Manufacturing, Engineering, and Validation teams.

The role requires hands-on calibration expertise, risk-based scheduling, and strong attention to regulatory requirements.

Qualifications

• High school education with 3+ years calibration experience in a regulated pharma/medical device environment.
• Experience with ISO 17025 accredited calibration providers.
• Working knowledge of QMSR, ISO 13485 and 21 CFR Part 11.
• Experience coordinating external calibration providers and reviewing certificates.
• Knowledge of out-of-tolerance handling and CAPA processes.
• Experience supporting product impact assessments for out-of-tolerance conditions.
• Strong written and verbal communication.
• Ability to work cross-functionally in a team.

Responsibilities

• Maintain and manage the site calibration program to ensure instruments are identified and scheduled for calibration within defined timelines.
• Keep calibration certificates and records audit-ready and traceable to standards.
• Support nonconformance investigations, CAPA and deviations related to calibration.
• Coordinate with external calibration providers and ensure ISO 17025 compliance.
• Assist in vendor qualification and equipment onboarding; decommission obsolete equipment.
• Provide SME support during audits and inspections and participate in improvements.

Skills

Calibrations

Metrology

Regulated environments

ISO 17025

QMSR/ISO13485

21 CFR Part 11

CAPA

Documentation

Education

High school diploma + 3 years calibration experience

Tools

Blue Mountain RAM

Job description

TEI BIOSCIENCES INC is seeking a Quality Calibration Technician II to manage the site calibration program in accordance with ISO 13485 and GMP standards. You will identify instruments, schedule calibrations, maintain records, and ensure audit-ready documentation while partnering with Facilities, Quality, Manufacturing, Engineering, and Validation teams.

The role requires hands-on calibration expertise, risk-based scheduling, and strong attention to regulatory requirements.