Quality Calibration Technician II

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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.

The Quality Calibration Technician will be responsible for reviewing and managing calibration for all the Braintree site equipment, as well as managing the calibration system to maintain compliance to internal procedures and external regulations.

• Lead and perform calibration (where necessary), verification, and adjustment of instruments and equipment in compliance with ISO 13485, and GMP requirements.
• Develop and maintain calibration schedules, ensuring timely completion of all required activities per regulatory standards.
• Administer and maintain CMMS (Blue Mountain RAM), ensuring accurate asset data, calibration intervals, work order tracking, and documentation.
• Create and maintain SOPs and work instructions for the lifecycle of calibrated assets in alignment with industry standards and best practices.
• Ensure calibration records are complete, traceable, and compliant with FDA, ISO, and internal standards.
• Troubleshoot and resolve calibration-related issues promptly while adhering to safety and compliance standards.
• Establish service agreements and maintain relationships with calibration vendors and equipment suppliers ensuring reliable, timely and appropriate calibration.
• Train and mentor junior technicians; act as a subject matter expert for calibration systems and compliance requirements.
• Support installation, qualification, and validation of new instruments and equipment, ensuring adherence to ISO and GMP protocols.
• Participate in investigations, root cause analysis, and continuous improvement initiatives related to measurement systems.
• Generate and analyze metrics (e.g., calibration completion rates, equipment downtime, backlog) to drive continuous improvement.
• Maintain accurate documentation of all calibration activities in CMMS or other approved systems, ensuring compliance with GDP.

• A minimum of a High School education is required with 3 years of applicable experience.
• 3+ years of calibration experience in a regulated pharma or medical device environment. A minimum of 3 years in a GMP and/or ISO regulated industry is required. Medical device inspection experience preferred.
• Hands‑on experience with CMMS platforms;
  Blue Mountain RAM (BMRAM) strongly preferred.
• Strong knowledge of ISO 17025, ISO 13485, FDA 21 CFR Part 11, and GMP compliance.
• Strong analytical, organizational, and communication skills.
• Ability to work independently and lead a team effectively.
• Proficiency in Microsoft Office Suite and data visualization tools.
• Experience with equipment calibration and calibration system management is required.
• Knowledge of Quality Engineering/Scientific methods and techniques.
• Expertise in measurement techniques and sampling plan definition (e.g., mechanical, optical, gages, automation).
• Strong computer skills and use of software applications (MS Word, Excel required) is required.
• Print reading and GD&T (Geometric Dimensioning and Tolerance) interpretation skills are preferred.
• Excellent written, oral communication and organization skills are required.
• Experience with systems such as Minitab, Track Wise, ETQ, and/or Oracle is preferred.
• Knowledge of international Standards: ISO 9000, ISO 13485, ISO 14971 is preferred.

• Experience in Biotech/Pharmaceutical or Medical Device manufacturing facilities.
• Familiarity with equipment qualification, calibration protocols, and validation lifecycle.
• Lean or Six Sigma certification is a plus.
• Excellent communication and time management skills.
• Ability to read and interpret engineering drawings, calibration certificates, and technical manuals.

Salary Pay Range:

$26.21 - $35.38 USD Hourly

In addition to base pay, employees may be eligible for bonus, commission, equity or other variable…