Instrumentation & Calibration Supervisor

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device company based in Austin, Texas is seeking an Instrumentation Supervisor responsible for overseeing the calibration management program for various facilities. The role includes hiring and training staff, ensuring compliance with regulations, and developing calibration plans. A Bachelor’s Degree and experience in metrology are essential. The position may require limited travel and involves working in calibration labs and manufacturing floors, adhering to safety standards.

Qualifications

• Strong background in metrology is preferred.
• 3 years’ experience as an Instrument Calibration Supervisor or Engineer or 8+ years as a Calibration Technician.

Responsibilities

• Hire, train, evaluate, and develop Calibration Department staff.
• Maintain cGMP compliance in all activities.
• Develop weekly calibration plans and schedule calibration activities.
• Ensure calibrated condition of all measurement instruments.
• Direct Calibration personnel in proper calibration and use of instruments.
• Participate in internal and external audits.

Skills

Metrology

Calibration management

Technical degree

Education

Bachelor’s Degree

Job description

Position Summary

Responsible for daily supervision and continuous improvement of the calibration management program for the instrumentation at the Austin and Round Rock facilities. 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.

The Instrumentation 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 at the Austin/Round Rock site.

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.
• 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 & Qualifications

• Strong background in metrology and/or technical degree preferred.

Education and Experience

• Bachelor’s Degree is required
• 3 years’ experience as an Instrument Calibration Supervisor or Engineer or 8+ years as a Calibration Technician.

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

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.