Supervisor, Instrumentation & Calibration

Position Summary:

The Instrumentation and Calibration Supervisor participates in the procurement and maintenance of the instrumentation used to measure the operation of production and lab facilities ensuring the safety of personnel, protection of the environment, and the reliability of processes used to manufacture products. Responsible for daily supervision and continuous improvement of the calibration management program.  Ensures all instrumentation meets specifications and is properly calibrated. Directly assigns and ensures the completion of daily calibration technician tasks.  Ensures appropriate training of calibration technicians completed on time. 

Essential Duties & Responsibilities:

• Hire, train, evaluate, develop Calibration Department staff.
• Maintain cGMP compliance in all activities. Improve instrument calibration, maintenance and documentation system consistent with all company, industry and regulatory requirements. 
• Attend plant scheduling meetings, develop weekly calibration plans and schedule calibration activities.
• Ensure calibrated condition of all measurement instruments and measuring devices to ensure operational reliability and regulatory compliance.  Participate in trouble-shooting process.
• Maintain accurate and up-to-date calibration records, including equipment details, calibration results, and certificates.
• Work within established spending and capital budgets for department.  Identify cost savings.
• Direct Calibration personnel in proper calibration and use of measuring equipment and calibration standards. Review all calibration documentation for thoroughness and accuracy. Maintain state-of-the-art knowledge of instrumentation and calibration practices.
• Act as calibration SME for validation, engineering, and laboratory instruments.
• Participate in internal and external audits.
• Develop and/or revise calibration procedures and standard operating procedures.
• Support cross-functional efforts to efficiently and effectively repair equipment and systems.
• Support CAPA investigations and implementation activities involving calibration instruments.
• Perform other related duties as assigned or required.

Knowledge, Skills:

• Strong background in metrology and/or technical degree preferred.
• Knowledge of the Medical Device Industry and FDA QSR regulations as they pertain to calibration.
• Ability to perform mathematical computations.
• Advanced knowledge of laboratory test equipment and strong mechanical aptitude.
• Advanced user knowledge of MS Office, statistical and enterprise resource programs.
• Ability to manage projects with emphasis on statistical analysis, technical writing and preparing validation protocols and reports.
• Self-directed, working with minimal to no direct supervision.

Minimum Qualifications, Education & Experience: 

• Must be at least 18 years of age.
• Bachelor’s Degree from an accredited college or university is required, preferably in Science, Technology, Engineering, or another related field.
• ASQ Certified Calibration Technician or ISA Certified Control Systems Technician preferred.
• Experience with calibration software and database management.
• Familiarity with calibration standards (e.g., ISO 9001, ISO 17025).
• 3 years’ experience as an Instrument Calibration Supervisor or Engineer. 
• In lieu of supervisory experience must have 5+ years as an Instrument Calibration Technician. 

Physical Requirements and Work Environment: 

• Calibration lab and calibration office environment. 
• Physical activity includes walking and moderate lifting. Since many of the calibration services are performed on the manufacturing floor, 
• Will be subject to activities in areas requiring PPE such as noise protection, safety shoes, safety glasses and fall protection. 
• Must be able to lift 50 lbs. unassisted.
• Typically requires travel less than 5% of the time.

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. 

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.