Job Openings >> Quality - Change Control Specialist
Quality - Change Control Specialist
Title:Quality - Change Control Specialist
Location:Buffalo, NY
Nissha is seeking a Change Control Specialist for the 1st shift (M-F)

Pay range starting at $19 per hour.

Nissha Medical Technologies (previously Graphic Controls) is a growing Buffalo based Company specializing in printed products for the gaming, medical, and recording supply markets. A global leader in these areas, Nissha is expanding into new markets and is looking for qualified candidates to grow with the Company. An entry level position allows you start with a Company with many growth and promotion opportunities, while providing job stability with an average length of service of over 15 years.

Job Summary:
Facilitates the Engineering Change Request (ECR) process owned by the Quality Department.  Ensures that all necessary requirements are completed/ reviewed by stakeholders in Quality, Engineering, Manufacturing, Marketing, Purchasing, and Tech Services prior to implementation of ECRs.  Ensures that the ECR moves through the stages in a timely fashion.

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

Physical Requirements:

Standing: Remaining upright on the feet, particularly for sustained periods of time. 50-75%

Handling: Seizing, holding, grasping, turning, or otherwise working with hand or hands. Also includes finger dexterity. 50-75%

Bending: Stooping, crouching, full back and leg flexibility. 0-25%

Kneeling: Bending legs at knees to come to rest on knee or knees. 0-25%

Reaching: Extending hand(s) and arm(s) in any direction. 25-50%

Lifting: Picking up and movement of objects. May involve carrying as well. 25-50%

Climbing: Ascending or descending using feet and legs and/or hands and arms. Body agility is emphasized. 0-25%

Vision: Ability to see and recognize detail. (Corrected or uncorrected.) 75-100%

Repetitive Motion: Recurring movement of the wrists, hands, and/or fingers. 25-50%

Pushing/Pulling: Using upper extremities to press against something with steady force to provoke movement, or to draw, drag, haul or tug objects in a sustained motion. 0-25%

Twisting: Moving in a contorted motion, usually involving the back, and usually repeatedly. 0-25%

Sitting: Remaining seated for a period of time, in one position. 75-100%
Walking: 50-75%

Great benefits offered including medical, dental, 401K, education assistance, and more!

Nissha Medical Technologies, is an Equal Opportunity Employer. Nissha Medical Technologies 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, Nissha Medical Technologies will provide reasonable accommodations for qualified individuals with disabilities.

If you need assistance with completing the online application process, please call Nissha Medical Technologies at (716) 847-7592

Alternatively, you can apply to this job using your profile on one of the following sites:

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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
The OEM trademarks identified herein are the trademarks of the respective OEMs, and not Nissha Medical Technologies. Nissha Medical Technologies disclaims any affiliation, connection or association between it's products and those of the respective OEMs.