Manufacturing quality engineering

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., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915).

Quality Engineer I

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., 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. 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 Engineer II is responsible for leading activities concerned with the application and maintenance of the Quality Management System for products and services offered by performing the essential functions and basic duties outlined in this job description. Other responsibilities include interfacing with internal and external customers on quality related aspects of development and sustaining projects.

Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or 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.

Abide by all safety and security rules set forth by the company and regulatory agencies.

Quality Assurance

Supports and establishes quality standards for products, processes, and procedures.

Investigate and analyze manufacturing, customer, and supplier problems.

Manage and investigate customer complaints, including DHR reviews.

Assist in troubleshooting line manufacturing, supervision, and engineering activities.

Determine and implement the test facilities and inspection required for quality assurance activity and methodologies.

Support and analyze outside service testing for internal and external customers (i.e. bioburden, sterilization, environmental monitoring).

Supports the development of plans to evaluate process repeatability and stability through equipment qualification and process validation. Assist with material compliance requests as assigned (REACh/RoHS/etc.).

Implement process improvements including fixtures, tools, production checks, testing, and inspection of devices.

Review and revise documentation and standards pertinent to production, design, and development.

Establish systems of measurement to improve the efficiency and adaptability of the business and production processes.

Acts as lead contact for customer audits.

Define and generate required documentation in support of assigned customer products and processes. Change orders, Engineering protocols, FMEAs, Control Plans, deviations, reports, work instructions, and procedures.

Maintain a high level of documentation that is clear and understandable, contains pertinent and accurate information, and will promote confidence with customers and auditors.

Bachelor’s Degree or equivalent experience/education

0-2 years of related experience, Medical Device preferred

Familiarity with Quality Systems and regulatory agencies. Demonstrated proficiency in MS Suite, particularly MS Word and Excel

Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals

Ability to work independently, at times with minimal supervision

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.

Nissha Medical Technologies is an Equal Opportunity Employer.