Quality Calibration Technician II

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

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.

SUMMARY

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.

ESSENTIAL DUTIES AND 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.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for this position.

• 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.

• 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, TrackWise, ETQ, and/or Oracle is preferred.

• Knowledge of international Standards: ISO 9000, ISO 13485, ISO 14971 is preferred

Preferred Skills

• 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

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

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

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.