Metrology Manager

Otsuka ICU Medical•Austin, TX

6d•Hybrid

About The Position

The Metrology Manager is responsible for establishing and executing a program of instrument calibration and maintenance for the Austin facility through the management of a calibration staff. Ensures all instruments meet current specifications and are properly calibrated. Generates and maintains calibration and preventative maintenance documentation for regulatory review. Ensures all departmental procedures meet corporate requirements. Provides troubleshooting and repair services of instruments.

Requirements

Requires excellent communication and interpersonal skills. Requires the ability to work with people and effectively communicate instructions and ideas clearly.
Requires excellent problem-solving skills. The ability to analyze situations and find effective solutions to problems.
Requires the ability to effectively time manage and be organized. High paced environment with multiple tasks, which requires the ability to self-prioritize tasks well.
Requires effective Leadership skills. Requires the ability to manage work primarily with supervisors. Must have the ability to motivate them and lead out on important initiatives.
Must be at least 18 years of age
Bachelor’s degree in Engineering or related discipline and/or equivalent experience in Professional Metrology Role.
Minimum 8 of years of experience required in a leadership role, within cGMP environment, five of which is in a leadership function within Operations or Engineering environment.
Minimum combination of eight years’ experience in one or more of the following areas: Calibration Supervisor, Controls Engineer, Metrology Manager, Process or Controls Engineering Manager.

Nice To Haves

Experience in a regulated industry or Military performing similar function preferred.

Responsibilities

Promotes safe work practices and ensures a safe work environment by adherence to all plant safety rules in areas of responsibility.
Administration of the calibration program ensuring scheduled and demand calibrations supporting batch release and validation testing are completed in a timely manner; reviewing and approving changes to instrument records and procedures; and reporting basic performance metrics.
Hire, develop, and supervise staff through personnel selection and development. Perform performance reviews, disciplinary actions, and other activities inherent to a manager role.
Maintain instrumentation/calibration/maintenance records and procedures in a manner that meets regulatory compliance. Completes assigned investigations, exception reports and corrective actions and preventive actions in a timely manner.
Interfaces with FDA and other external and internal auditors as a technical expert for instrument calibration.
Ensures a rapid response to address instrumentation/calibration related issues impacting operations. Responsible for troubleshooting instrumentation and related systems.
Selection and configuration of instrumentation, controls and related equipment to support new projects and continuous improvement efforts.
Establishes and maintains metrics to meet departmental objectives.