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Global Supplier Quality Engineer

Nissha Medical Technologies

Buffalo, New York

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JOB DETAILS
SKILLS
Analysis Skills, Code of Federal Regulations, Communication Skills, Compensation Management, Continuous Improvement, Contract Manufacturing, Corrective Action, Cross-Functional, Detail Oriented, Documentation Review, Documentation Standards, Emerging Technology, External Audit, FDA (Food and Drug Administration), Healthcare, ISO (International Organization for Standardization), Industry Standards, Internal Audit, Maintain Compliance, Medical Equipment, Microsoft Excel, Microsoft Word, Performance Analysis, Performance Metrics, Problem Solving Skills, Product Support, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Regulations, Risk, Risk Management, Standard Operating Procedures (SOP), Standards Development, Team Player, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Relations, Vendor/Supplier Selection, Willing to Travel
LOCATION
Buffalo, New York
POSTED
Today
JOB DESCRIPTION

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.

What You Will Do

Nissha Medical Technologies is looking for a Global Supplier Quality Engineer. This position is responsible for managing external suppliers to ensure compliance with the Supplier Controls set forth in NMT's Quality Management System and all applicable regulations and standards. Controls include the approval and qualification of suppliers, ongoing evaluation, rating, monitoring and supplier audits. Other responsibilities include interfacing with suppliers on quality related aspects components and raw materials.

  • Evaluate legacy supplier control programs across multiple sites to ensure compliance to regulations and standards.
  • Develop and maintain standardized processes for supplier selection, evaluation, and monitoring based on risk across multiple sites.
  • Develop and maintain standardized processes for material compliance across multiple sites to ensure compliance.
  • Identify and lead assigned continuous improvement projects for either suppliers or internal cross-functional teams
  • Manage applicable supplier corrective actions to assure effectiveness and avoid repeat issues.
  • Collection and evaluation of supplier key performance metrics to ensure effectivity and compliance with NMT Quality management System(s).
  • Facilitate and host business reviews with applicable suppliers on regular frequencies dependent on risk.
  • 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.
  • Investigate and analyze non conformances and compliance in relation to supplier issues.
  • Review documentation and standards pertinent to supplier controls.
  • Help determine and implement component/ raw material inspection specifications/ criteria required for quality assurance activities.
  • Participate in internal and external audits
  • 25% travel requirement
  • What You Bring

    Core Qualifications
  • Minimum of 3 years of related experience
  • Familiarity with Quality Systems and regulatory agencies. Preferably ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820.
  • Bachelor's Degree (BA or BS) from a four-year College or University

    Preferred Qualifications
  • Medical device experience preferred
  • Demonstrated proficiency in MS Suite, particularly MS Word and Excel

    Professional Traits We Value
  • Demonstrates excellent communication skills, team player, results oriented in a demanding environment.
  • Problem-solving aptitude and attention to detail
  • Ability to react quickly to changes

Compensation & Benefits

The expected salary range for this position is $75,000- $95,000 annually. Actual compensation will be determined based on experience, skills, qualifications, and geographic location.

In addition, Nissha Medical Technologies offers a competitive

About the Company

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Nissha Medical Technologies