Our client is a large pharmaceutical company based in Dublin for over 25 years.
Due to sustained growth and a large expansion project, they are looking to hire a Supplier Quality Engineer to assist the larger quality team.
The Position Reporting to the Senior Supplier Quality Engineer, this position supports the Supplier Quality Management (SQM) program and oversees all quality-related aspects of materials used across the business.
Key responsibilities include:
Managing supplier onboarding and monitoring processes in line with supplier management procedures.Maintaining supplier files, including qualification documents, monitoring records, and up-to-date certifications.Determining supplier criticality by collaborating with engineering teams and suppliers.Liaising with suppliers to obtain and review approval documentation.Generating supplier and incoming quality metrics for scorecards and management reviews.Resolving quality issues with suppliers using the NC/SCAR process and driving quality improvement initiatives.Managing the return of samples or lots to suppliers when required.Representing supplier quality in new product and supplier qualification projects.Conducting supplier audits and maintaining supplier quality agreements as needed.Performing technical evaluations of new suppliers and raw materials.Ensuring inventory control of materials awaiting inspection and maintaining an up-to-date approved supplier list.The Person The successful candidate will have the following qualifications, skills, and experience:
A third-level qualification in Engineering, Quality, or Science.At least 2 years of experience in a Medical Device or Pharmaceutical environment, with practical knowledge of highly regulated quality management systems (QMS).Proficiency in quality systems such as ISO 13485 is essential.
Familiarity with 21 CFR Part 820, EU GMP, and Eudralex Volume 4 is advantageous.An understanding of injection molding processes is a plus.Strong knowledge of validations, change control management, statistics, and SPC in a Medical Device environment.Excellent communication skills, both written and verbal.Auditing experience to ISO 13485, EU GMP, or 21 CFR Part 820 standards is preferred.Familiarity with Lean/6 Sigma tools is desirable.To discover more about this opportunity please apply online or contact Lewis Murray on +353 87 204 3307 for a confidential discussion.
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