Change Control Specialist III

Nissha•Buffalo, NY

9d•$63,000 - $75,000

About The Position

Nissha Medical Technologies is seeking a Change Control Specialist III to join its Quality team in Buffalo, New York. The position 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 or review required items before ECR implementation. The specialist also ensures ECRs progress through their stages in a timely manner. The role facilitates changes to medical device product and component specifications, prepares and routes ECRs and deviations, and maintains associated logs and records. It manages active and obsolete Master Device Records, controlled copies, finished-goods and component information, packaging drawings, and label artwork records. The specialist also reviews artwork, updates certain drawings and specifications, supports departments with product details, helps resolve specification-record discrepancies, manages assigned projects, and updates work instructions, forms, and operating procedures as requested.

Requirements

Minimum Associate degree.
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 preferred.
Experience with Microsoft Office and Oracle preferred.

Responsibilities

Facilitate new and revised medical device product and component specifications through ECRs, coordinating required actions with relevant departments before implementation.
Provide ECR numbers, prepare ECRs, and route them for signatures.
Identify deviations from current procedures, drawings, specifications, and work instructions, and create and route Deviations as needed.
Manage ECR and Deviation Logs.
Maintain Master Device Records by moving approved revisions to active records and outdated revisions to obsolete records.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.