Change Control Specialist III

Nissha • Buffalo, NY

7d • $63,000 - $75,000

About The Position

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.

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.

Requirements

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

Nice To Haves

• Oracle ERP/PLM or similar software preferred.
• Minimum five years proven experience in a technical support role preferred.
• Prior experience in medical device manufacturing or other highly regulated manufacturing environment.
• Experience with Microsoft Office & Oracle preferred
• Excellent project management skills
• Strong collaboration abilities
• Able to coordinate numerous, diverse, detailed activities concurrently
• Excellent communication skills; both written and verbal
• Self-motivated
• Detail oriented
• Able to work independently, as well as in a team setting

Responsibilities

• 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.

Benefits

• Nissha Medical Technologies offers a competitive total rewards package including medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 11-50 employees