Metrology Manager: Calibration & Compliance Lead

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin, TX is seeking a Metrology Manager to lead calibration and maintenance for the facility, ensuring instruments meet specifications and regulatory standards. You will oversee a calibration staff, develop documentation, and drive continuous improvement in metrology practices.

The role involves coordinating with auditors and internal teams, troubleshooting instrumentation issues, and establishing performance metrics.

Qualifications

• Must have a bachelor’s degree in Engineering or related discipline or equivalent experience in professional metrology.
• Minimum 8 years in a leadership role within a cGMP environment, with operations or engineering focus.
• Experience in calibration supervision or metrology management in regulated settings preferred.

Responsibilities

• Promotes safe work practices and maintains a safe environment.
• Administers calibration program to support batch release and validation testing.
• Hire, develop and supervise staff; conduct performance reviews and related activities.
• Maintain calibration records and procedures to meet regulatory compliance.
• Interface with FDA and auditors as a technical calibration expert.
• Troubleshoot instrumentation and related systems; address issues impacting operations.
• Select and configure instrumentation and equipment for projects and improvements.
• Establish and maintain metrics to meet departmental objectives.

Skills

Strong communication

Problem solving

Leadership

Time management

Education

Bachelor’s degree in Engineering or related field

Equivalent metrology leadership experience

Job description

Otsuka ICU Medical LLC in Austin, TX is seeking a Metrology Manager to lead calibration and maintenance for the facility, ensuring instruments meet specifications and regulatory standards. You will oversee a calibration staff, develop documentation, and drive continuous improvement in metrology practices.

The role involves coordinating with auditors and internal teams, troubleshooting instrumentation issues, and establishing performance metrics.