Integra LifeSciences · 3 days ago
Quality Calibration Technician II
US-MA-Braintree-220-Facility
Full-time
Onsite
Mid Level
$26.21/hr - $35.38/hr
3+ years expIntegra LifeSciences is a company that focuses on innovating new treatment pathways to advance patient outcomes. The Quality Calibration Technician will be responsible for managing calibration for all site equipment and ensuring compliance with internal procedures and external regulations.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
Required
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 (for example, mechanical, optical, gages, automation)
Strong computer skills and use of software applications (MS Word, Excel required) is required
Excellent written, oral communication and organization skills are required
Knowledge of international Standards: ISO 9000, ISO 13485, ISO 14971 is preferred
Preferred
Medical device inspection experience preferred
Print reading and GD&T (Geometric Dimensioning and Tolerance) interpretation skills are preferred
Experience with systems such as Minitab, TrackWise, ETQ, and/or Oracle 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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Company data provided by crunchbase