Quality Coordinator

JOB DESCRIPTION Quality Coordinator 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.

The Quality Coordinator is responsible for ensuring the quality and conformance of manufactured products and assemblies at Nissha Medical Technologies by performing the essential functions listed below. Additional responsibilities include coordinating outside service activities and maintaining records of calibration, environmental monitoring, and customer- required testing results.

• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies, and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
• Demonstrate knowledge and acts in accordance with NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.
• Abide by all safety and security rules set forth by the company and regulatory agencies.
• Complete incoming Receiving Inspections as time allows.
• Regular attendance is required.

• Responsible for final audit of product after all manufacturing and testing has been performed per the MAI and applicable work instructions.
• Assist with basic dimensional inspections as needed.
• Ensure that product that does not conform to specifications is prevented from being used or delivered.
• Communicate with Quality Inspectors, Quality Technicians, Engineers and all stakeholders for correcting and/or dispositioning of nonconforming products.
• Maintain appropriate records to complete the evidence of conformance, specifically on the job sheet.
• Help gather necessary product release documents per customer requirements for device shipment.
• Create the Certificate of Conformance for the device shipment.

• Act as EAM Administrator for all devices and equipment at Nissha Medical Technologies.
• Maintain records of calibration.
• Ensure Preventive Maintenance work requests are completed and closed.
• Review, approve, and implement EAM Asset Requests.
• Install equipment at appropriate locations throughout the facilities.
• Ensure equipment is properly maintained, labeled, and stored in established locations.
• Manage the calibration and PM schedules for all equipment in EAM and ensure all equipment is properly calibrated, labeled, and controlled.
• Remove from service equipment that is damaged or no longer in use.
• Coordinate calibration with established outside services when equipment is due.
• Initiate nonconformance investigations for equipment found damaged or out of calibration.

• Coordinate quarterly environmental monitoring with approved agency.
• Coordinate annual particulate testing of for certified clean rooms with approved agency.
• Coordinate bioburden and LAL testing of products and components with approved agency.
• Coordinate sterilization services as required by the customer with approved agency.
• Maintain records per established procedures.

• Responsible for performing and documenting in-process audits in production areas.

• High School Diploma or General Education Degree (GED)
• Minimum 3 years of experience in a manufacturing environment and/or quality control role.
• Knowledge of QMS…