MDR Supplier Quality Engineer

Highly Competitive
  1. Permanent
  2. Validation
  3. United States
West Chester, Pennsylvania
Posting date: 07 Mar 2019

ProClinical is advertising a vacancy for an MDR Supplier Quality Engineer position with a leading global advisor of talent supply chain strategies. This company, which is one of the largest workforce management solutions companies in the world, is seeking for an applicant to join their team in Pennsylvania.

The MDR Supplier Quality Engineer will become a working member of the technical file remediation efforts and ensure externally manufactured products meet EU MDR requirements. This includes supporting project deliverables, meeting project timelines, resolving identified supplier issues, and executing the overall project related to technical file remediation requirements. This is a fantastic opportunity to work with an organization that specializes in multiple scientific and engineering sectors.

Job Responsibilities:

  • Assessing supplier drawings and processing information to support project deliverables.
  • Manufacturing Process Information.
  • Overseeing production risk management files
  • Overseeing validation protocols and reports.
  • Directing part-marking documentation.
  • Working with Suppliers to meet EU MDR requirements and resolving issues with obtaining Supplier Product information.
  • Cross-coordinating workstream activities/interdependencies with other workstream and project teams.
  • Partnering with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities.
  • Supporting the definition and clarification of EU MDR supplier related process requirements.
  • Supporting Review and Approval EU MDR Change Projects as applicable.
  • Supporting Supplier Quality Functional Impact Assessments as applicable.
  • Reviewing and approving supplier Process Validation Protocols and Reports as applicable.
  • Supporting the update of supplier related Inspection Criteria as applicable.

Skills and Requirements:

  • A minimum of a bachelor's degree or equivalent in Engineering or associated technical field is required.
  • A minimum of three years' experience in Quality Engineering.
  • A minimum of two years' experience in the Medical Device and/or Pharmaceutical Industry.
  • Familiarity with ISO 13485 and FDA QSR.
  • Three years' experience as Supplier Quality and Supplier Process Validation engineer.
  • Demonstrable experience as a Project Engineer, Project Manager or equivalent role within regulated industry.
  • An understanding of supplier management, validation procedures, and execution.
  • Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
  • Experience working with suppliers across multiple sites and franchises.
  • Ability to act as an SME in supplier business processes.
  • Experience with medical device technical files.
  • Ability to balance multiple tasks to meet priorities and timelines.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

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 contact Maya Smith at + 267-405-6995 or upload your CV on our website -

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.