Senior Calibration Metrology Specialist - Elkton, United States - Terumo Medical Cooperation

Description

At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting.

This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products.

Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.

Job Summary

This position is responsible for supporting the site calibration program.

Perform calibration activities for production and laboratory equipment throughout equipment life cycle to internal SOPs and external standards and guidelines.

Document results and prepare technical reports for the calibration and assist in managing any deviation from expected results.

Job Details/Responsibilities

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Maintain calibration schedule and assist with the PM of the equipment with vendors.
• Assist in maintaining vendor calibration records and other associated documents.
• Perform calibration activities to support IQ / OQ / PQ of new/modified and relocation activities.
• Work collaboratively with Engineering, Production, Quality Assurance, and IT departments to ensure strict compliance with GMP guidelines, specifically to ensure that equipment is maintained in GMP compliance
• Provide input in the selection of measuring/test equipment.
• Assign identification numbers to new measuring/test equipment.
• Assist in review of existing calibration procedures to ensure compliance with requirements (internal & vendor's) and accuracy.
• Troubleshoot, test, repair and optimize instruments, equipment, and control systems.
• Work collaboratively with vendors to request services as applicable for resolution of issues.
• Write Standard Operating Procedures and Test methods for equipment.
• Manage change controls for equipment documents.
• Appropriately document service on instruments including calibration incidents.
• Identify and communicate to management out of tolerance equipment and drive to resolution.
• Escort vendors on-site to perform maintenance activities on instruments on contract.
• Provide and oversee training for associates performing any aspect of internal calibrations and/or processing external calibrations.
• Participate actively in metrics calibration activities.
• Calibration subject matter expert, requiring participation in internal and external audit activities
• Perform other related duties as assigned.

Qualifications/ Background Experiences

Requires a minimum of an associate degree in engineering, life sciences, or related degree and a minimum of five years of experience in related field.

Bachelor's Degree preferred. Intermediate computer software skills, i.e. Microsoft Office. Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.

Terumo Cardiovascular is an equal opportunity employer.

We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information.

EOE Minorities/Women/Disabled/Veterans


Nearest Major Market:
Philadelphia