Global Supplier Quality Engineer

Nissha•Buffalo, NY

2d•$75,000 - $95,000

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.