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Principle Supplier Quality Engineer

Location: Galway
Reference no. : 1680
Date added: 29/07/2020
Salary: €Neg




Description

 

Principle Supplier Quality Engineer


The Principle Supplier Quality Engineer (Staff Supplier Quality Engineer) is a member of the Supplier Quality Engineering team. They are responsible for Supplier Quality within their prescribed area of functional responsibility. The successful candidate will lead and work as part of a team to maintain high quality / performance standards on all clients products. Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision.

Our clients Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.

 

Job Responsibilities

 -       Supervision and direction of Supplier Quality personnel (Engineer and Technician grade). 

-       Lead and drive Supplier QA initiatives within area of functional responsibility.

-       Provide supplier quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions. 

-       Investigating root cause of supplier issues (SCAR) and ensuring follow-through of timely and effective corrective actions to prevent re-occurrence.  

-       Strategically lead new material introduction and support new product launches to ensure Supplier Quality meets the required standards.  

-       Lead and support (as an auditor) various audits of a diverse supplier base. 

-       Perform on site supplier visits for root cause analysis and verification of corrective actions of supplier quality issues.  

-       Reporting functional Supplier Quality metrics. 

-       Preparation of Supplier Quality reports for various meetings and management forums. 

-       Review Supplier Manufacturing processes. Collaborate with suppliers on process improvement and value enhancement opportunities.  

-       Facilitate the escalation of unresolved Supplier Quality issues. 

-       Ownership of the Material Review Board process within the Galway site. 

-       Lead a team of incoming inspectors ensuring the quality of supplied components meet the company&rsquos requirements. 

-       Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements 

-       Develop strong links with customer organizations and other project stakeholders.  

-       Supporting internal and external audits to ISO and FDA requirements. 

-       Performing an active role in further development and continuous improvement of the quality management system. 

-       Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.


Qualifications 

-       Level 8 degree in Science / Engineering or related fields essential.  

-       Minimum of 7yrs industry experience in a medical device manufacturing environment.

Key Requirements 

-       Clear understanding medical device quality systems and requirements, including measurement techniques, would be a distinct advantage. 

-       Strong CAPA experience. 

-       Strong root cause analytical and problem solving skills.  

-       Strong working knowledge of FDA, ISO & MDSAP Quality system regulations for Medical device companies desirable. 

-       Auditor certification and experience desired. 

-       Demonstrated excellent organizational skills and ability to work on own initiative essential. 

-       Supervisory experience desirable. 

-       Experience in development and coaching. 

-       Excellent written and verbal communication skills essential. 

-       Willingness to travel.

      For further information, please contact Bernie on +353 93 41932 or e-mail your cv to bernie.dempsey @bdr.ie



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