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Supplier Quality Engineer - Europe

Summary

**Title:** Supplier Quality Engineer - Europe

**ID:** 2680

**Department:** Quality

**Location:** Paignton, England

Description

Nissha Medical Technologies is excited to be looking for a **Supplier Quality Engineer** to support our sites in the UK and France. This position can sit in one of our European offices or work remote with travel required.

Essential Functions and Responsibilities

+ Execute and comply with global supplier control procedures and processes, including upholding, educating and enforcing said procedure(s) within the European Operations.

+ Develop and/or remediate specifications of raw materials and components outsourced from vendors and hold suppliers accountable to agreed upon specifications.

+ Management and remediation of supplier quality agreements.

+ Approve and qualify new and legacy suppliers as per global procedures.

+ Act as main interface for all supplier quality requirements for specific products or components.

+ Monitor and report on supplier key performance indicators through scorecards, business reviews, external certifications, periodic business reviews. Maintain and execute standardized processes for material compliance across multiple sites to ensure compliance.

+ Responsible for anything in Material Review Board that is SCAR related, and is an overall Stakeholder in all European Operations sites MRB.

+ Identify and lead assigned continuous improvement projects for either suppliers or internal cross-functional teams.

+ Review and collaborate with Design Engineering and Operations in material / component specification.

+ Identify opportunities for product, specification or process improvements within the supply chain, the operations and engineering to enhance quality and efficiency.

+ Manage applicable supplier corrective actions to assure effectiveness and avoid repeat issues.

+ 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 conformance's 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.

Experience, Knowledge, Skills and Attributes

+ Minimum of 3 years of related QE (or similar) experience (Medical Device preferred)

+ 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. Engineering or a related field, preferred.

+ 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.

+ European, Swiss or UK citizenship

_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._