Job Information
Terumo Cardiovascular Group Senior Calibration Metrology Specialist - 2nd Shift in Elkton, Maryland
Senior Calibration Metrology Specialist - 2nd Shift
Date: Jun 22, 2024
Req ID: 3107
Location:
Elkton, MD, US, 21921
Company: Terumo Cardiovascular USA
Department: MD General Management
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.
At Terumo we’re working to build a healthier, happier society for our associates and the world. Our story begins over 100 years ago in Japan. Since then, we’ve been united by our mission to contribute to society through healthcare. As an associate at Terumo, your work helps to shape our evolution for the future. Working as one team, learning, innovating and challenging ourselves to write the future of healthcare. And no matter the location, no matter the team, we look out for one another, respect and support each other, strengthening trust with patients and healthcare providers everywhere.
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.
This is a 2nd shift position: Monday - Friday 2pm - 11pm.
Benefits:
120 hours pro-rated vacation
Medical, dental, vision – 1st of the month following 30 days.
14 company paid holidays, including a week off at Christmas.
401k with 6% company match
Incentive Plan Bonus - Every May
Life insurance & short term disability – can also pay more into this in addition to what Terumo offers.
Paid parental leave & Employee Assistance Program
Tuition reimbursement, scholarship program, mentoring program, other wellness initiatives
Diversity Equity & Inclusion and Associate Resource Groups
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