Calibration Specialist

Cook Medical Inc.; Bloomington (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Cook Inc - Bloomington is seeking a Calibration Specialist I to perform and support calibration and repair of IM&TE in a cGMP environment, ensuring accuracy across electrical, temperature, mechanical, and analytical measurements using traceable standards.

You will maintain calibration program records, contribute to QSPs and change controls, collaborate with Facilities, Production Engineering, R&D and Quality, and adhere to FDA/ISO requirements while maintaining safety and punctual

Qualifications

• Associates Degree or equivalent in calibration/instrumentation.
• 2 years experience in calibration preferred.
• Familiarity with cGMP and ISO regulations.
• Knowledge of CCMS administration.

Responsibilities

• Perform calibration of IM&TE and support calibration across equipment.
• Maintain calibration program tracking all equipment and cGMP systems.
• Follow methods based on measurement science and accuracy requirements.
• Assist with generation of QSPs, calibration instructions, deviation investigations, and change control docs.
• Interface with Facilities, Production Engineering, R&D, Quality and Admin teams.
• Coordinate with approved service suppliers for calibration of equipment and systems.
• Maintain training requirements and seek continuous development.
• Adhere to Quality Management System and regulatory requirements.

Skills

Calibration knowledge

Documentation

Communication

Education

Associates Degree in a technical discipline

Tools

CCMS

MS Office

Job description

Calibration Specialist

Company: Cook Inc - Bloomington

Location: Bloomington IN United States

Job Locations: US-IN-Bloomington

Position Type: Full Time

Category: Facilities/Maintenance

Overview

The primary function of the Calibration Specialist I is to perform and support calibration and repair of Inspection, Measurement and Test Equipment, (IM&TE), while maintaining compliance to the Quality System. This position is responsible for execution and continuous improvement of calibration and repair of IM&TE parameters such as electrical/electronic, temperature, physical, dimensional, humidity, frequency, torque, mass, and analytical measurements using traceable reference standards, following work order instructions, and adhering strictly to cGMP requirements.

Responsibilities

• Perform calibration of IM&TE, provide support to organization on new and existing equipment potentially needing calibration.
• Ensure maintenance of the calibration program tracking all equipment associated with cGMP equipment and systems.
• Follow and ensure compliance to methods and techniques based on principles of measurement science, technical analysis of measurement issues, accuracy and precision requirements.
• Assist with generation of QSPs, calibration instructions, deviation/failure investigations, change control documentation, and reports.
• Interface with various business functions including Facilities, Production Engineering, R&D, Quality, and Administration teams.
• Correspond with approved service suppliers to ensure appropriate calibration of equipment, instruments, and systems.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Qualifications

• Associates Degree in a technical discipline specific to calibration and instrumentation, or experience of such kind and amount as to provide a comparable background.
• 2 years of experience in calibration and instrumentation preferred.
• Awareness of Computerized Calibration Management Software (CCMS) administration and management.
• Awareness of cGMP, CFR 820 and ISO regulations.
• Knowledge of Microsoft Word, Excel, and Outlook.
• Ability to travel approximately 10% as necessary to other facilities.
• Must be able to perform reasonable job functions requiring periods of sitting, standing, walking, communicating.
• Utilizes close visual acuity for working with computers, etc.

EEO Statement

“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.