Manager, Calibration & Metrology

Integra LifeSciences

Plainsboro Township (NJ)

On-site

USD 109,000 - 150,000

Full time

12 days ago
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Job summary

Integra LifeSciences is hiring a Manager of Calibration & Metrology to provide technical leadership and operational management of the site calibration and metrology program. The role ensures compliance with FDA, GMP, ISO 13485 and other regulatory requirements.

Reporting to the Director, Engineering, the candidate will supervise Calibration Technicians, CMMS resources, contractors and calibration service providers while leading continuous improvement and audit readiness across ~2,500 assets and

Qualifications

  • Bachelor’s degree in related discipline; 8+ years leading a team.
  • Deep knowledge of metrology principles and calibration techniques.
  • Experience with calibration management software (ProCal, Blue Mountain).
  • Ability to read engineering drawings and schematics.
  • Strong knowledge of FDA, GMP, ISO 13485 and measurement uncertainty.

Responsibilities

  • Lead the site calibration and metrology program for ~2,500 assets and 3,000+ annual calibration events.
  • Manage departmental goals, budget, staffing, KPIs and audit readiness.
  • 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 certificate review.
  • Manage CMMS asset records, scheduling, recalls, onboarding and retirement of assets.
  • Lead supervisor and technicians, drive continuous improvement, compliance, and safety.

Skills

Metrology principles
Calibration techniques
Leadership
Reading drawings
FDA/GMP knowledge
English communication
MS Office & statistics
Self-motivated
Cross-functional collaboration

Education

Bachelor’s degree in related discipline

Tools

ProCal
Blue Mountain

Job description

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

Position will directly manage 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.
  • Demonstrate excellent organizational and English communication skills (oral & written)
  • Financial acumen relating to investment opportunities, continuous improvement P&L impacts, etc.
  • 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:

This role requires regular use of tools and equipment relevant to the work environment. Examples include:

  • 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

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties.

While performing the responsibilities of this role, the employee is expected to:

  • 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.
Salary Pay Range:

$109,250.00 - $149,500.00 USD Salary

Our salary ranges are determined by role, level, and location. 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 . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you’d like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

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