Calibration Program Lead - Metrology & Compliance

Anika; Bedford (MA); Vor Ort; USD 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Discretionary bonus

Healthcare benefits

Health savings account

401(k) plan with company match

Employee stock purchase plan

Paid time off

Long-term incentives

Zusammenfassung

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.

Qualifikationen

• 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

Aufgaben

• 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

Kenntnisse

Calibration leadership

People management

Cross-functional collaboration

Regulatory compliance

Data analysis

CMMS experience

Ausbildung

Bachelor’s degree in Engineering or related technical discipline

Tools

Blue Mountain RAM

Jobbeschreibung

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.