Job Openings >> Change Control Specialist
Change Control Specialist
Title:Change Control Specialist
Location:Buffalo, NY
Nissha Medical Technologies is looking for a Change Control Specialist to facilitate the Engineering Change Request (ECR) process owned by the Quality Department. In this role, they will ensure that all necessary requirements are completed/ reviewed by stakeholders in Quality, Engineering, Manufacturing, Marketing, Purchasing, and Tech Services prior to implementation of ECRs, as well as ensure that the ECR moves through the stages in a timely fashion.

Essential Job Functions
1.    Facilitates all new and revised medical device product and component specifications via ECR. Coordinates required actions by Marketing, Sales, Pre-Press, Purchasing, Materials Management, and Quality Control prior to the implementation of any ECR’s.
2.    Provide ECR number, build ECR, and route for signature.
3.    Identifies deviations to current procedures, drawings, specifications, and work instructions and creates/ routes Deviations as needed. 
4.    Manages ECR and Deviation Logs. Move approved revisions into Master Device Records (active) and old revisions to Obsolete. Manage hard copy Master Device Records (active and obsolete). Manage Master List of all finished goods and components for revision history, dates, controlled copies, and additional information.
5.    Approve artwork proofs from vendors. Approve artwork of first piece incoming labels, pouches, inserts, and other components with artwork. Send artwork proofs and ECRs (when required) to customers through customer service or product manager.
6.    Manage controlled copies of packaging drawing/label artwork books in packaging/labeling area.
7.    Update electrode and packaging drawings for typos and changes that do not require an Engineer.
8.    Build/update Specs and IIR’s as needed. Maintain current and accurate specification files.
9.    Provides internal product detail support for all departments. Co-ordinate resolution of specific product specification record discrepancies.
10.    Manages assigned projects as needed.
11.    Make changes to WI, Forms, or OPs as requested.

•    Minimum Associate degree, Bachelor’s degree preferred.  Experience with Microsoft Office and Oracle preferred. 

Knowledge, Skills, and Abilities
•    Excellent project management skills
•    Strong leadership abilities
•    Able to coordinate numerous, diverse, detailed activities concurrently
•    Excellent communication skills; both written and verbal
•    Self-motivated
•    Detail oriented
•    Good math skills
•    Experience with Microsoft Office & Oracle preferred

Nissha Medical Technologies is an Equal Opportunity Employer; and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
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Nissha Medical Technologies
400 Exchange Street
Buffalo, NY 14204
Nissha Medical Technologies is the medical devices business unit and wholly owned subsidiary of Nissha Co. Ltd., a Japanese publicly held company based in Kyoto, Japan (TSE:7915).
Copyright 2020 Nissha Medical Technologies. All rights Reserved
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