PM/CAL Coordinator I - US
JOB SUMMARY
JOB TITLE: PM/CAL Coordinator I
FUNCTION: Operations
SUB FUNCTION: Production
LOCATION: Danvers, MA, United States
DATE POSTED: Sep 15 2023
REQUISITION NUMBER: 00001K0L
DESCRIPTION
Abiomed, part of Johnson & Johnson MedTech is recruiting for a PM/CAL Coordinator I located in Danvers, MA.
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians.
Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
The PM/Cal Coordinator I will be responsible for supporting and coordinating preventative maintenance and calibration for all departments (including but not limited to production and engineering) in the Danvers facility. The equipment is maintained according to specific requirements and are documented in the equipment database. This includes scheduled calibration, maintenance, and/or verification activities.
Principle Duties & Responsibilities:
> Enter the results of PM and Calibration into the equipment record system
> Maintain a PM and Calibration information database with equipment specifications, accuracy, and other information relevant to the equipment PM and Calibration program
> Maintain Master Material information for all equipment, including Equipment Hazard Assessments
> Perform in-house calibrations per internal proceduresInteract with internal personnel and contract PM and calibration laboratories to coordinate events
> Initiate paperwork and notify personnel of equipment found to be out of acceptable limits or missingPrepare monthly reports identifying equipment due for calibration, maintenance, or verification activities.
> Retrieve equipment for identified location to prepare for scheduled activities, such as maintenance or calibration.
> Coordinate with calibration vendors for calibration of equipment. Send equipment to vendors or arrange for on-site calibration.
> Coordinate with maintenance vendors to perform maintenance activities. Send equipment to vendors or arrange for on-site maintenance
> Ensure identified vendors are included on the approved vendor list or submit request to add new vendors.
> Obtain quote for calibration and/or repair of equipment, return material authorizations, etc. from vendors.
> Process Purchase Requests as needed for vendor services, including maintenance and calibration.
> Receive equipment from vendors, review and approve calibration reports for completeness and accuracy.
> Generate quality notifications for non-conforming equipment.Notify area owners if equipment is found non-conforming (out of tolerance, damaged, etc.) and obtain impact assessments.
> Add new equipment to the equipment database, including reviewing form, labeling, identify requirements, ensure completeness of forms.
> Remove equipment from use when expired, broken, or otherwise retired from use.
> Maintain equipment database and associated calibration records, impact assessment forms and other documentation, as applicable.
> Additional responsibilities may include focus on one or more departments or locations.
Qualifications
Job Qualifications:
> Minimum 1 year of related quality systems experience, preferably within a regulated industry
> Excellent written and verbal communication.
> Efficient data entry using computer keyboard.Knowledge and experience in SAP preferred.
> Ability to work with limited supervision, multi-task, and possesses attention to detail.
> Experience in FDA regulated environment, pertinent to GMPs and ISO 13485 preferred.
> Basic knowledge of 21 CFR Part 11 compliance is a plus.Knowledge of MS tools including MS Office Suite, Adobe
About the Company
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.
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