Quality Coordinator

Nissha•Colorado Springs, CO

21d•$22 - $26•Onsite

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.

Requirements

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 principles, concepts, systems, industry practices, and standards.
Highly organized, detail oriented, and works effectively as both a team member and independent contributor.
Demonstrated proficiency in MS Suite, particularly in Microsoft Word and Excel.
Ability to work independently with minimal supervision.
Ability to clearly communicate (oral & written) and work well with employees at all levels.
Acts with sound and proactive judgement, seeking clarification as appropriate to minimize/eliminate delays.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
Ability to write routine reports and correspondence.
Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
Ability to deal with problems involving several concrete variables in standardized situations.

Nice To Haves

Working knowledge of basic metrology and using measurement tools and equipment preferred.
Proficiency using scheduling programs/databases preferred.

Responsibilities

Ensuring the quality and conformance of manufactured products and assemblies by performing essential functions.
Coordinating outside service activities.
Maintaining records of calibration, environmental monitoring, and customer-required testing results.
Following 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.
Demonstrating knowledge and acting in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
Abiding by all safety and security rules set forth by the company and regulatory agencies.
Completing incoming Receiving Inspections as time allows.
Performing final audit of product after all manufacturing and testing has been performed per the MAI and applicable work instructions.
Assisting with basic dimensional inspections as needed.
Ensuring that product that does not conform to specifications is prevented from being used or delivered.
Communicating with Quality Inspectors, Quality Technicians, Engineers and all stakeholders for correcting and/or dispositioning of nonconforming products.
Maintaining appropriate records to complete the evidence of conformance, specifically on the job sheet.
Helping gather necessary product release documents per customer requirements for device shipment.
Creating the Certificate of Conformance for the device shipment.
Acting as EAM Administrator for all devices and equipment at Nissha Medical Technologies.
Maintaining records of calibration.
Ensuring Preventive Maintenance work requests are completed and closed.
Reviewing, approving, and implementing EAM Asset Requests.
Installing equipment at appropriate locations throughout the facilities.
Ensuring equipment is properly maintained, labeled, and stored in established locations.
Managing the calibration and PM schedules for all equipment in EAM and ensuring all equipment is properly calibrated, labeled, and controlled.
Removing from service equipment that is damaged or no longer in use.
Coordinating calibration with established outside services when equipment is due.
Initiating nonconformance investigations for equipment found damaged or out of calibration.
Coordinating quarterly environmental monitoring with approved agency.
Coordinating annual particulate testing of for certified cleanrooms with approved agency.
Coordinating bioburden and LAL testing of products and components with approved agency.
Coordinating sterilization services as required by the customer with approved agency.
Maintaining records per established procedures.
Performing and documenting in-process audits in production areas.