Anika · 4 weeks ago
Lead Calibration Technician
Bedford, MA, US
Full-time
Hybrid
Senior Level, Lead/Staff
$60K/yr - $80K/yr
5+ years expAnika is a company that specializes in the manufacturing of medical devices. They are seeking a Lead Calibration Technician to oversee calibration activities for critical instruments and equipment within a GMP manufacturing facility, ensuring compliance with relevant standards and regulations.
BiotechnologyHealth CareManufacturingTherapeutics
Responsibilities
Lead and perform calibration, verification, and adjustment of instruments and equipment in compliance with ISO 17025, ISO 13485, and GMP requirements
Develop and maintain calibration schedules, ensuring timely completion of all required activities per regulatory standards
Administer and maintain CMMS (preferably 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
Participate in on-call rotation for off-hour emergencies and weekend walkthroughs as needed
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience)
5+ years of calibration experience in a regulated pharma or medical device environment
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
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
Discretionary bonus program for all full-time employees
Comprehensive healthcare benefits
Health savings account
401(k) plan with up to 5% company match which includes immediate vesting
Employee stock purchase plan at a 15% discount
Accrued paid time off
Additional long-term incentives including stock awards
Company
Anika
Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care.
201-500 employees
H1B Sponsorship
Anika 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 (3)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
Caligan Partners
2024-03-07Post Ipo Equity
1993-05-14IPO
Leadership Team
Cheryl Blanchard
President and CEO
Recent News
GlobeNewswire
2026-01-09
2026-01-09
2025-12-31
Company data provided by crunchbase