Change Control Specialist III

Nissha Medical Technologies•Buffalo, NY

8d•Onsite

About The Position

Nissha Medical Technologies is seeking a Change Control Specialist III to join its Quality team in Buffalo, New York. The role facilitates the Engineering Change Request (ECR) process owned by the Quality Department, ensuring that stakeholders across Quality, Engineering, Manufacturing, Marketing, Purchasing, and Technical Services complete and review required actions before ECR implementation. The specialist helps move ECRs through each stage in a timely manner and facilitates new and revised medical device product and component specifications through ECRs. The position also manages deviations, ECR and deviation logs, device records, product and component master lists, specifications, and controlled copies of packaging and labeling materials. It supports artwork proof review and approval, coordinates customer communications about proofs and ECRs, resolves product specification record discrepancies, and takes on assigned projects and document updates.

Requirements

Associate degree minimum; a Bachelor’s degree is preferred.
Excellent written and verbal communication skills.
Self-motivated and detail-oriented.
Good math skills.
Excellent project management skills.
Strong leadership abilities.
Ability to coordinate numerous diverse, detailed activities concurrently.

Nice To Haves

Bachelor’s degree.
Experience with Microsoft Office.
Experience with Oracle.

Responsibilities

Facilitate the Quality Department’s Engineering Change Request (ECR) process and ensure required stakeholder reviews and actions are completed before implementation.
Ensure ECRs progress through their stages in a timely manner.
Facilitate new and revised medical device product and component specifications through ECRs.
Coordinate actions with Marketing, Sales, Pre-Press, Purchasing, Materials Management, and Quality Control before ECR implementation.
Provide ECR numbers, prepare ECRs, and route them for signatures.
Identify deviations from current procedures, drawings, specifications, and work instructions; create and route deviations as needed.
Manage ECR and Deviation Logs.
Maintain Master Device Records by moving approved revisions into active records and outdated revisions into obsolete records.
Manage hard-copy active and obsolete Master Device Records.
Maintain the master list of finished goods and components, including revision history, dates, controlled copies, and other information.
Approve artwork proofs from vendors and first-piece incoming artwork for labels, pouches, inserts, and other components.
Send artwork proofs and ECRs to customers through Customer Service or the Product Manager when required.
Manage controlled copies of packaging drawings and label artwork books in the packaging and labeling area.
Update electrode and packaging drawings for typographical errors and changes that do not require an Engineer.
Create and update specifications and IIRs as needed, and maintain current and accurate specification files.
Provide internal product detail support to departments and coordinate resolution of product specification record discrepancies.
Manage assigned projects as needed.
Update work instructions, forms, and operating procedures as requested.