Change Control Specialist III

Job Description 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 Facilitate the Engineering Change Order (ECO) and QMS Change Order (CO) processes owned by the Quality Department, ensuring that all necessary requirements are completed/reviewed by the appropriate stakeholders prior to implementation of ECOs & COs. Ensure that the ECO/CO moves through the workflow in a timely fashion. Execute technical updates within Oracle ERP/PLM to new and existing products, including BOM, routes, purchase specifications, labels, drawings, component/product/process documentation, and related updates. Adhere to document retention requirements. Initiate ECOs and QMS COs, move COs through the workflow, and ensure proper approvals are received within Oracle. Identify deviations and/or nonconformances to current procedures, drawings, specifications, and work instructions, creating and routing deviations as needed. Manage ECOs and deviation logs, ensuring approved revisions are incorporated into active Master Device Records (MDRs) and that superseded revisions are transitioned to Obsolete status. Verify accuracy and consistency of all revision levels and item/document statuses within Oracle. Facilitate customer communication by routing artwork proofs and applicable ECOs through Customer Service or the Product Manager, in accordance with established procedures. Oversee the control, maintenance, and distribution of controlled procedures and other quality system documents. Maintain product and packaging drawings by implementing typographical corrections and minor revisions that do not require Engineering involvement. Build/update specifications and incoming inspection records (IIRs) as needed, maintaining current and accurate specification files. Provide internal product detail support for all departments, identifying discrepancies and facilitating resolution of product specification records. Manage assigned projects as required, ensuring timely and effective completion. Implement revisions to work instructions (WIs), forms, and standard operating procedures (SOPs) as requested and in accordance with document control requirements. Coordinate document review cycles by routing documents for required approvals at defined intervals and ensuring timely completion. Maintain high attention to detail. Train and support the development of new staff members as it relates to document control and product lifecycle management. Communicate clearly and professionally, both verbally and in written correspondence. Exhibit a positive attitude and collaborate 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 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. Professional Traits We Value 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. Compensation & Benefits The expected salary range for this position is $63,000‑$75,000 annually. Actual compensation will be determined based on experience, skills, qualifications, and geographic location. In addition, 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. Equal Opportunity Statement Nissha Medical Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected status under applicable law. #J-18808-Ljbffr Nissha Medical Technologies