Supplier Quality Engineer

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP)
  3. Germany
Hamburg
Posting date: 24 Jan 2019
QA.KD.21237_1548330462

ProClinical is excited to announce that a new job opportunity has arisen for a Supplier Quality Engineer position with one of the most renowned pharmaceutical, medical device and consumer health organisations in the world. This organisation, which is a top 10 pharma company, is looking for a hard-working Supplier Quality Engineer to join their team in Germany.

The incumbent will be responsible for the integration of 3D-Printed Spinal Implant Vendors onto the company's ASL. Furthermore, this position will ensure that current supplier controls within the company's QMS are maintained, whilst working with the vendors to document/improve process controls to ensure seamless integration onto the ASL. The Supplier Quality Engineer will provide Quality Leadership for the control of multiple 3D-Printed Spinal Implant Ems, and ownership will include Supplier Quality relationship through final release.

This is a contracted role.

Job Responsibilities:

  • Providing Quality point of contact with select Ems.
  • Working at select Supplier and EM locations.
  • Remediating quality documentation.
  • Conducting Process Capability Studies.
  • Managing the vendor in creation/execution of Validation Studies as required.
  • Developing supplier proficiency in risk assessment such as PFMEA.
  • Managing training and certification of operators and inspectors to CTQs with the suppliers as required.
  • Developing and implementing efficient and effective inspection points.
  • Conducting on-site quality and process assignments at Ems to approve new suppliers and ongoing assessment of established suppliers.
  • Reviewing and approving Validation of production processes.
  • Designing and validating processes where appropriate.
  • Participating and leading in design for manufacturability evaluations where appropriate for Supplier Quality related projects.
  • Ensuring robust supplier risk management plans (based on risk categorisation) are established and executed in line with company strategy for risk identification.
  • Actively supporting the overall strategy for risk identification, mitigation, and communication.
  • Resolving problems and eliminating constraints to ensure project and supply targets are met.
  • Ensuring suppliers meet change control requirements.
  • Generating Quality metrics on supplier performance and establishing measures to monitor quality costs and cost avoidance.
  • Communicating and assuring appropriate implementation of Quality Process Specifications (QPS) and Raw Material Specifications (RMS), etc.
  • Ensuring effective and timely closure on all Supplier Corrective Action Requests.
  • Maintaining standards of housekeeping and GMP requirements.
  • Assisting in the development, implementation, and review of standard operating procedures in Internal and External Relationships.

Skills and Requirements:

  • A minimum of a bachelor's degree or equivalent in engineering.
  • Three years' experience as a Supplier Quality Engineer/Supplier Process Validation Engineer/Project Engineer/Project Manager, or equivalent role within regulated industry.
  • A strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
  • Experience working with suppliers across multiple sites and franchise.
  • Experience with medical device technical files.
  • Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations as desired.
  • Proficiency with Microsoft Office Suite.
  • Experience in CAPA execution and management.
  • Fluency in written and oral German.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kelechi Dyke on +44 203 854 0200 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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