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Change Control Specialist III

Nissha Medical Technologies

Buffalo, New York

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JOB DETAILS
SKILLS
Agile PLM / Oracle PLM (Product Lifecycle Management), Bill of Materials (BOM), Change Control, Change Requests/Orders, Communication Skills, Continuous Improvement, Contract Manufacturing, Cross-Functional, Customer Support/Service, Detail Oriented, Distribution Control, Document Control, Emerging Technology, Engineering Change Order, Healthcare, Medical Equipment, Medical Products, Microsoft Office, Oracle, Oracle ERP, Procedure Development, Product Documentation, Product Lifecycle Management, Product Management, Product Packaging, Product Support, Project/Program Management, Staff Development, Standard Operating Procedures (SOP), Team Player, Time Management, eCos
LOCATION
Buffalo, New York
POSTED
Today
JOB DESCRIPTION

About Nissha Medical Technologies

Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915).

Across our global organization, our teams collaborate to design and manufacture innovative medical devices and solutions that make a real difference in patients' lives. We partner closely with our customers to solve complex challenges, move ideas forward, and support products from concept through commercialization. Our work spans patient monitoring, surgical and interventional solutions, precision components, and emerging technologies, all grounded in a strong culture of quality, accountability, and continuous improvement.

At Nissha Medical Technologies, we believe our success is driven by our people. We foster an environment where curiosity is encouraged, teamwork is valued, and individuals are empowered to grow their skills and careers. If you're motivated by meaningful work, collaboration, and the opportunity to help shape the future of healthcare, you'll find a place to belong at NMT.

What You Will Do

Nissha Medical Technologies is looking for a Change Control Specialist III to join our Quality team. This position facilitates the Engineering Change Order (ECO) and QMS Change Order (CO) processes owned by the Quality Department. Ensures that all necessary requirements are completed/reviewed by the appropriate stakeholders prior to implementation of ECOs & COs. Ensures that the ECO/CO moves through the workflow in a timely fashion.

Responsible for executing technical updates within Oracle ERP/PLM to new and existing products under the direction of stakeholders. Updates may include bill of materials (BOM), routes, purchase specifications, labels, drawings, component/product/process documentation, etc. Adheres to document retention requirements.
  • Facilitates all new and revised medical device product and component specifications via ECO. Coordinates required actions prior to the implementation of any ECOs.
  • Initiate ECOs and QMS COs, move COs through the workflow, and ensure proper approvals are received within Oracle.
  • Identifies deviations and/or nonconformances to current procedures, drawings, specifications, and work instructions and creates/ routes deviations as needed.
  • Manages ECOs and deviation logs. Ensures approved revisions are incorporated into active Master Device Records (MDRs) and that superseded revisions are appropriately transitions to Obsolete status. Verifies accuracy and consistency of all revision levels and item/document statuses within Oracle.
  • Facilitates customer communication by routing artwork proofs and applicable ECOs through Customer Service or the Product Manager, in accordance with established procedures.
  • Oversees the control, maintenance, and distribution of controlled procedures and other quality system documents.
  • Maintains product and packaging drawings by implementing typographical corrections and minor revisions that do not require Engineering involvement, in accordance with established procedures.
  • Build/update specifications and incoming inspection records (IIRs) as needed. Maintain current and accurate specification files.
  • Provides internal product detail support for all departments. Identify discrepancies and facilitate resolution of product specification records.
  • Manages assigned projects as required, ensuring timely and effective completion.
  • Implements revisions to work instructions (WIs), forms, and standard operating procedures (SOPs) as requested and in accordance with document control requirements.
  • Coordinates document review cycles by routing documents for required approvals at defined intervals and ensuring timely completion.
  • Maintain high attention to detail.
  • Trains and supports the development of new staff members as it relates to document control and product lifecycle management.
  • Communicates clearly and professionally, both verbally and in written correspondence.
  • Exhibits a positive attitude and collaborates effectively with cross-function teams across the organization.
  • Perform other tasks as assigned by management.
What You Bring

Core Qualifications
  • Minimum Associate degree, Bachelor's degree preferred.
  • Experience with Microsoft Office required.
Preferred Qualifications
  • Orac

About the Company

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Nissha Medical Technologies