Change Control Specialist III

About the role

Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. As the medical devices business unit of Nissha Co., Ltd., a publicly traded Japanese company, NMT focuses on designing and manufacturing innovative medical devices and solutions that improve healthcare outcomes. The company fosters a collaborative environment where employees can contribute to advancing the field of medicine.

Responsibilities

• Facilitates the Engineering Change Order (ECO) and QMS Change Order (CO) processes owned by the Quality Department.
• Ensures all necessary requirements are completed/reviewed by appropriate stakeholders before implementing ECOs & COs.
• Maintains technical updates within Oracle ERP/PLM for new and existing products, including BOM, routes, purchase specifications, labels, drawings, component/product/process documentation, etc.
• Adheres to document retention requirements.
• Facilitates creation and routing of new and revised medical device product and component specifications via ECO.
• Coordinates required actions for ECOs and ensures proper approvals within Oracle.
• Identifies deviations and nonconformances, and creates/routes deviations as needed.
• Manages ECOs and deviation logs, ensuring approved revisions are incorporated into active MDRs and superseded revisions are transitioned to Obsolete status.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.
• 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.
• Builds/update specifications and incoming inspection records (IIRs) as needed.
• Maintains current and accurate specification files.
• Provides internal product detail support for all departments.
• Identifies discrepancies and facilitates 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.
• Captures and coordinates document review cycles by routing documents for required approvals at defined intervals.
• Maintains 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 writing.
• Exhibits a positive attitude and collaborates effectively with cross-functional teams across the organization.

Qualifications

• Minimum Associate degree, Bachelor’s degree preferred.
• Experience with Microsoft Office required.
• Preferred qualifications include Oracle ERP/PLM or similar software experience.
• 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.

Skills

• Excellent project management skills.
• Strong collaboration abilities.
• Excellent communication skills; both written and verbal.
• Self-motivated.
• High attention to detail.
• Ability to work independently, as well as in a team setting.

Benefits

The expected salary range for this position is $63,000– $75,000 annually. Additional benefits include medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities.