Calibration Supervisor

Anika Therapeutics, Inc.; Bedford (MA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

Health savings account

401(k) plan with company match

Employee stock purchase plan

Paid time off

Long-term incentives

Job summary

Anika is seeking a Calibration Supervisor for our Bedford, MA facility to lead the site calibration program and a team of calibration technicians and contractors, ensuring accuracy, reliability, and compliance in a regulated life sciences environment.

This role blends leadership with technical expertise, including establishing calibration intervals, maintaining RAM records in Blue Mountain RAM, and driving continuous improvement while supporting audits.

Qualifications

• Bachelor’s degree required in engineering or related technical discipline with regulated industry experience considered
• 7+ years in calibration/metrology/maintenance/quality systems within regulated life sciences or medical device environments
• 2+ years in supervisory or people-management roles and cross-functional leadership

Responsibilities

• Lead, coach, and develop calibration technicians and contractors, assign work, set priorities, monitor performance, and support development
• Own the site calibration program and ensure calibration, verification, adjustment, and documentation are completed on schedule and in compliance with regulatory and quality requirements
• Develop, implement, and maintain calibration policies, SOPs, work instructions, forms and job aids for calibrated assets
• Establish and maintain site calibration strategy, including risk-based criticality assessments, intervals, acceptance criteria, and traceability
• Maintain calibration records in Blue Mountain RAM with accurate asset data, schedules, certificates, and compliance documentation
• Review calibration records, deviations, out-of-tolerance assessments, and corrective actions in partnership with QA and Operations
• Serve as calibration SMEs during audits, inspections, change controls, equipment qualifications and validation activities
• Manage relationships with third-party calibration providers and service vendors, including agreements, scheduling, and performance expectations
• Collaborate cross-functionally to support equipment reliability, compliance, and uptime
• Develop and report calibration metrics (schedule adherence, backlog, overdue work orders, audit observations)
• Identify opportunities to improve calibration processes, reliability, and program effectiveness
• Provide training on calibration practices, Good Documentation Practices, CMMS use, procedure changes, and regulatory requirements
• Participate in on-call rotation and emergency response as needed

Skills

Calibration leadership

People management

Cross-functional collaboration

Regulatory compliance

Data analysis

CMMS experience

Education

Bachelor’s degree in Engineering or related technical discipline

Tools

Blue Mountain RAM

Job description

What You’ll Do

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.

How You’ll Contribute

• 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.

What It Takes

You’re a technical leader who understands that a strong calibration program is about more than keeping equipment on schedule. You know how to balance compliance, reliability, risk and business needs while leading a team and working across functions. You’re comfortable serving as the technical expert, digging into problems, making sound decisions and improving the systems and processes behind the work.

What You Bring

• 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 Have

• 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.

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education and geographic location. Anika also offers a 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 and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market‑leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

On‑site