Quality Inspector II

Nissha•Colorado Springs, CO

7h•$21 - $23•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 2 years of related experience, Medical Device preferred.
Demonstrated proficiency in MD Suite, particularly Microsoft (MS) Word and Excel.
Knowledge of GD&T and able to read and interpret drawings/specifications.
Familiarity with standard inspection tools to include calipers, micrometers, optical comparator, scales, and pin gauges.
Must be highly organized, detail oriented, and work effectively as both a team member and independent contributor.
Strong written and oral communication skills.
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 deal with problems involving several concrete variables in standardized situations.
Well-developed verbal, numerical reasoning, and analysis skills with ability to draw sound conclusions.

Nice To Haves

Previous experience designing fixtures or tooling is preferred
Vision System and CMM operation experience preferred.
ASQ CQI preferred.

Responsibilities

Verifying incoming raw materials, in-process, and final product to ensure that materials that do not conform to specification are prevented from being used or delivered.
Maintaining appropriate records to complete the evidence of conformance.
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 regulations are met.
Demonstrate knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
Inspection of components and documentation for purchased product.
Inspect product using standard inspection gages such as micrometers and vernier/calipers, optical comparators, and visual coordinate measurement systems.
Inspection of product using visual standards.
Testing of product using tensile testing equipment.
Use of good documentation practices (GDP) of inspection results for presentation to Material Review Board and inspection history files.
Generate Quality Material Reports (QMR) to document discrepant materials.
Process dispositioned material after inspection and/or MRB activities.
Maintain accurate Inspection Record files.
Interact with all levels of company team members.
Perform In-Process and Final Inspections where applicable.
Gather sterilization and other external records for inclusion into the Device History Record (DHR).
Provide lot release documentation to customers as required.
Review and approve the final DHR packet authorizing release of product.
Assist with production re-inspection activities as needed.
Support internal/external audits by providing evidence as requested.
May be required to work overtime when necessary.
Other duties or special projects may be assigned as requested.
Abides by all safety and security rules set forth by the company and regulatory agencies.
Regular attendance is required.