Calibration Supervisor

Anika Therapeutics•Bedford, MA

3d•$66,000 - $82,000•Hybrid

About The Position

As the Calibration Supervisor, you’ll lead Anika’s site calibration program and the team responsible for keeping our critical equipment and instruments accurate, reliable, and ready for use. Working in a regulated life sciences and medical device manufacturing environment, you’ll oversee calibration technicians and contractors while ensuring calibration activities are completed safely, on time, and in compliance with regulatory and quality requirements. You’ll serve as the site subject matter expert for calibration and metrology, partnering closely with Facilities, Engineering, Manufacturing, Quality, Validation, Metrology, and EHS. This role combines people leadership, technical expertise, program ownership, and continuous improvement, with an opportunity to strengthen and evolve the site’s calibration program. This position is primarily on-site at our Bedford, MA facility, with some flexibility for hybrid work depending on operational priorities, audit readiness, project needs, and team coordination.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Metrology, or a related technical discipline; equivalent combination of education and regulated industry experience may be considered.
7+ years of experience in calibration, metrology, maintenance, engineering, or quality systems within a regulated life sciences, biotechnology, pharmaceutical, diagnostics, or medical device environment.
2+ years of supervisory, lead, or people-management experience, including work assignment, coaching, performance feedback, and team development.
Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 11, cGMP, Good Documentation Practices, traceability, and calibration program requirements.
Familiarity with ISO 17025 principles.
Demonstrated ability to write, revise, implement, and train others on procedures, policies, work instructions, and quality-system documentation.
Hands-on experience with CMMS platforms; Blue Mountain RAM strongly preferred.
Strong analytical, organizational, communication, audit-support, and cross-functional leadership skills.
Proficiency with Microsoft Office Suite and the ability to analyze calibration data, trends, and performance metrics.

Nice To Haves

Experience supervising calibration teams supporting medical device, diagnostics, biotechnology, pharmaceutical, or combination-product manufacturing.
Experience building or maturing calibration programs, including SOP structure, policy ownership, audit readiness, and equipment lifecycle management.
Familiarity with equipment qualification, calibration protocols, process validation, computerized systems, and change control.
ASQ, CCT, metrology, Lean, Six Sigma, or related certification.
Ability to read and interpret engineering drawings, calibration certificates, technical manuals, specifications, and quality records.

Responsibilities

Lead, coach, and develop a team of calibration technicians and contractors, including assigning work, setting priorities, monitoring performance, and supporting individual development.
Own the site calibration program and ensure calibration, verification, adjustment, and documentation activities are completed on schedule and in compliance with regulatory, quality, and safety requirements.
Develop, implement, and maintain calibration policies, SOPs, work instructions, forms, and job aids covering the full lifecycle of calibrated assets.
Establish and maintain the site calibration strategy, including risk-based criticality assessments, calibration intervals, acceptance criteria, measurement uncertainty considerations, and traceability requirements.
Administer and maintain calibration records in Blue Mountain RAM, ensuring accurate asset data, schedules, work orders, certificates, traceability records, and compliance documentation.
Review and approve calibration records, deviations, out-of-tolerance assessments, impact evaluations, corrective actions, and related quality documentation in partnership with Quality Assurance and Operations.
Serve as the calibration subject matter expert during internal and external audits, inspections, investigations, change controls, equipment qualifications, and validation activities.
Manage relationships with third-party calibration providers, equipment suppliers, and service vendors, including service agreements, scheduling, performance expectations, documentation quality, and issue resolution.
Partner cross-functionally with Facilities, Engineering, Manufacturing, Quality, Validation, Metrology, and EHS to support equipment reliability, compliance, and uptime.
Develop and report calibration metrics, including schedule adherence, backlog, overdue work orders, audit observations, out-of-tolerance trends, vendor performance, and equipment downtime.
Identify opportunities to improve calibration processes, reliability, documentation, and program effectiveness.
Provide training and technical guidance on calibration practices, Good Documentation Practices, CMMS use, procedure changes, and regulatory requirements.
Participate in on-call rotation, off-hour emergency response, system walk-throughs, and business continuity activities as needed.