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Job Title:  Document Control Coordinator

Req ID:  18438
Job Category:  Quality
Country/Region:  US
State:  OH
City:  Mentor
Zip:  44060
Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

 

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Position Summary

Support all tasks associated with the generation, review and/or updating of documentation related to manufacturing, packaging, testing, raw material and finished products, specifications, rework and the conformance to applicable regulatory compliance, as well as applying, when needed, the applicable government regulations during the engineering change process, to ensure compliance. Must be proficient and have knowledge in the current Product Data Management (PDM/EPDM) (i.e. PLM) System, MRP (i.e. AS400) software and Oracle.

Duties
  • Change Administrator for the PLM Process: Responsible for analyzing submitted ECRs/ECNs including the evaluation, clarification, and acceptance of an ECR/ECN and assigning the appropriate Review Board (CCB/CRB) based on the type of change according to established Quality Systems Procedures. This position is a critical role in processing day to day engineering changes for the facility.
  • Generate and revise documentation as required utilizing the appropriate software application such as; Word, Excel, AutoCAD etc.
  • Fulfill the responsibility as Change Administrator when required to do so as defined by the PLM Corporate Standards and the facilities Quality System Procedures. This pertains to procedures, work instructions and op. sheets, etc.
  • Assists in providing the necessary insight during the engineering change process (work flows, ECN Implementation Plan structure, identifying where objects/changes are in the PLM process etc.) regardless of where changes are initiated.
  • Initial entry of assigned part numbers and descriptions, build Bills of Materials, enable part numbers, define product coding and accounting in accordance with Financial Procedures, update revision levels and transfer data into appropriate organizations within the Oracle Database and AS400 Database.
Duties - cont'd
  • Participate in software validations as required.
  • Update and maintain the facility Training Matrix per engineering change process. Also maintain the facilities shared network drive for released, revised and archive documentation which are revised outside the PLM environment.
  • Maintain the calibration system database. Provide or design reports using Crystal Report software as necessary for data sets relating to the facility within Calman.
  • Supports timely and proper launch of all new products.
  • Perform other duties as assigned.
Required Experience
  • Associate degree in a related field required.  Minimum of 2-5 years experience in Engineering or Manufacturing environment required.
  • Must be proficient in computer skills including but not limited to Microsoft applications, CDA, Oracle and the AS400 system.
  • Position requires remaining stationary for extended periods of time at a computer as well as performing tasks in an air conditioned office and factory environment.
  • The duties of this position are generally performed in an office and/or laboratory environment.  Duties may require some standing, and sitting for long periods.  Associates may occasionally be exposed to mechanical, electrical, chemical, or biological experiments or components.  Possible exposure to periodic pungent odors, fumes, airborne particles, and biological agents.  Exposure to intermittent high noise levels is possible.  Position requires travel to Customer(s), vendor(s), industry trade shows or other work related locations.#ZR

 

STERIS strives to be an Equal Opportunity Employer.  


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

Job Segment: Document Control, Engineer, Chemical Research, Electrical, Administrative, Engineering, Quality