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., 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.

Responsibilities

• 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. Regular attendance is required.

Quality Assurance

• Ensures compliance with cGMP and established procedures in all areas of the company.
• Supports and establishes quality standards for products, processes, and procedures.
• Provide support for design and development activities, including development of FMEAs and Control Plans.

Problem Solving

• Investigate and analyze manufacturing, customer, and supplier problems.
• Manage and investigate customer complaints, including DHR reviews.
• Own supplier control nonconformances and SCARs as necessary.
• Initiate and own CAPAs as necessary.
• Assist in troubleshooting line manufacturing, supervision, and engineering activities.

Analysis

• Assists with performing and supporting capability studies, GR&Rs, and first articles.
• 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.
• Apply appropriate statistical methodologies.
• Assist with material compliance requests as assigned (REACh/RoHS/etc.).
• Lead internal open item and company metric review meetings where assigned.

Continuous Improvement

• 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.

Audits

• Participate in internal and external audits.
• Acts as lead contact for customer audits.

Documentation

• Define and generate required documentation in support of assigned customer products and processes. These may include: 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.

Requirements

Core Qualifications

• Bachelor’s Degree or equivalent experience/education
• 0-2 years of related experience, Medical Device preferred
• Familiarity with Quality Systems and regulatory agencies. Preferably ISO 13485 and FDA 21 CFR 820
• 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 write routine reports and correspondence
• Ability to apply logical and systematic understanding to carry out instructions furnished in written, oral, or diagram form.

Preferred Qualifications

• Certification through ASQ as a CQE preferred
• ISO 13485 and FDA 21 CFR 820 preferred

Skills

• Highly organized, detail-oriented, and works effectively as both a team member and independent contributor
• Ability to work independently, at times with minimal supervision
• Acts with sound and proactive decision making, seeks clarification as appropriate to minimize/eliminate delays
• Team-player

Pay

The expected salary range for this position is $65,000 – $75,000 annually. Actual compensation will be determined based on experience, skills, qualifications, and geographic location.

Benefits

• Medical, dental, and vision coverage
• 401(k) with company match
• Paid time off
• Life and disability insurance
• Professional development opportunities