Job Summary
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. 
Essential Job Functions
1. Evaluate legacy supplier control programs across multiple sites to ensure compliance to regulations and standards. 
2. Develop and maintain standardized processes for supplier selection, evaluation, and monitoring based on risk across multiple sites. 
3. Develop and maintain standardized processes for material compliance across multiple sites to ensure compliance. 
4. Identify and lead assigned continuous improvement projects for either suppliers or internal cross-functional teams
5. Manage applicable supplier corrective actions to assure effectiveness and avoid repeat issues.
6. Collection and evaluation of supplier key performance metrics to ensure effectivity and compliance with NMT Quality management System(s). 
7. Facilitate and host business reviews with applicable suppliers on regular frequencies dependent on risk. 
8. 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.
9. Demonstrate knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
10. Investigate and analyze non conformances and compliance in relation to supplier issues.
11. Review documentation and standards pertinent to supplier controls. 
12. Help determine and implement component/ raw material inspection specifications/ criteria required for quality assurance activities.
13. Participate in internal and external audits
Requirements

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

Knowledge, Skills & Abilities

• Highly organized, detail oriented and works effectively as both a team member and independent contributor
• Demonstrated proficiency in MS Suite, particularly MS Word and Excel
• Ability to work independently, at time with minimal supervision
• Acts with sound and proactive decision making, seeks clarification as appropriate to minimize/eliminate delays
• 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.
• Ability to deal with problems involving several concrete variables in standard situations

Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression,national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call 716-849-6495.