Manager, Calibration & Metrology

About the role

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. The Manager, Calibration & Metrology is responsible for providing technical leadership and operational management of the site calibration and metrology program while fulfilling Senior Metrology Engineer and Calibration Engineer responsibilities. The role ensures compliance with FDA, GMP, ISO 13485, ISO 9001 and applicable regulatory requirements.

Reporting & Management Scope

• Supervision Received: Under direct supervision of the Director, Engineering
• Supervision Exercised: Directly manages Calibration Technicians, CMMS resources, contractors and calibration service providers

Key Responsibilities

• Lead the site calibration and metrology program supporting approximately 2,500 assets and over 3,000 annual calibration events
• Manage departmental goals, budget, staffing, KPIs and audit readiness activities
• Serve as site metrology expert for measurement uncertainty, traceability and calibration standards
• Lead out-of-tolerance investigations and calibration interval optimization
• Develop, approve, and maintain calibration procedures and work instructions
• Oversee vendor calibration providers and calibration certificate review
• Manage CMMS asset records, scheduling, recalls, onboarding and retirement of assets
• Lead supervisor and technicians, and support continuous improvement, compliance, and safety initiatives
• Complete other job-related duties as assigned

Skills & Competencies

• Bachelor’s degree in related discipline with 8+ years leading a team (direct reports) or equivalent education and years of management experience
• Deep knowledge of metrology principles and various calibration techniques
• Proficiency with calibration management software (e.g., ProCal, Blue Mountain)
• Ability to read and interpret engineering drawings, technical manuals, and schematics
• Strong knowledge of FDA, GMP, ISO 13485, measurement uncertainty, MSA, and technical writing
• Excellent organizational and English communication skills (oral & written)
• Financial acumen relating to investment opportunities, continuous improvement P&L impacts
• Proficiency in MS Office Suite and statistical analysis software
• Experience in regulated environment; medical device or pharma preferred
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization

Tools And Equipment Used

• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems
• Software and systems: CMMS systems, QMS software, ERP systems
• Calibration standards, pressure, temperature, electrical and dimensional calibration equipment

Physical Requirements

• Sit, listen, speak, and move throughout various areas of the building
• Travel across all company locations as needed
• Periodically lift and/or move items up to 25 pounds
• Travel domestically and internationally via car, train, or airplane, as required by the role

Pay

Salary Pay Range: $109,250.00 - $149,500.00 USD. 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.

Benefits

• Medical, dental, vision insurance
• Life insurance
• Short- and long-term disability
• Business accident insurance
• Group legal insurance
• Savings plan (401(k))