Quality Engineers, Validation Consultant - Senior

Highly Competitive
  1. Permanent
  2. Validation
  3. Switzerland
Posting date: 25 Mar 2019

ProClinical is advertising a vacancy for a Quality Engineer, Validation Consultant - Senior position with one of the most prestigious pharmaceutical companies in the world. Internationally renowned for their work across a range of industries, the organisation is currently broadcasting this attractive vacancy to be based in their Swiss office. This is an exciting opportunity to work with a top 10 company whose work spans medical devices to pharmaceutical and consumer goods.

The Quality Engineer will evaluate the suppliers manufacturing process information and production risk management, along with directing part marking documentation against MDR Requirements.

Job Responsibilities:

  • Ensuring all externally manufactured company products meet new 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. *
  • Collaborating with suppliers to obtain details for manufacturing process information, production risk management, and direct part marking.
  • Assessing supplier drawings and process information to support project deliverables:
    • Direct part marking documentation.
    • Manufacturing Process Information.
    • Production risk management file.
    • Validation protocols and reports.
  • Working with Suppliers to meet EU MDR requirements and resolve 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, defining, and clarifying EU MDR supplier related process requirements.
  • Supporting Review and Approval EU MDR Change Projects as applicable.
  • Supporting Supplier Quality Functional Impact Assessments as applicable.
  • Supporting Reviews and Approvals of supplier Process Validation Protocols and Reports as applicable.
  • Supporting the update of supplier related Inspection Criteria as applicable.
  • Knowing and following all applicable laws and policies and maintaining the highest levels of professionalism, ethics, and compliance at all times.

Skills and Requirements:

  • A minimum of a Bachelor's degree or equivalent in engineering or associated technical field.
  • At least 3 years of experience as a Project Engineer, Quality Engineer, Project Manager, or equivalent role within regulated industry.
  • At least 3 years of experience in a supervisory capacity.
  • At least 2 years of experience in a medical device and/or pharmaceutical industry.
  • At least 3 years of experience in a quality engineering field.
  • At least 2 years of experience in the medical device and/or pharmaceutical industry is required.
  • A familiarity with ISO-13485 and FDA QSR.
  • Experience with systems implementation/rollout projects preferred.
  • Experience in a Medical Device regulated environment.
  • Familiarity with ISO 13485 and FDA QSR is required.
  • Understanding supplier validation procedures and execution.
  • Strong understanding of the critical path, program resources, setup project plans and track execution, and establishing project structure and governance around critical projects.
  • Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
  • Experience with GD&T, Inspection Methods, and Drawing Review/Approval.
  • Experience working with suppliers across multiple sites and business centres.
  • Process Excellence Black Belt or Master Black Belt.
  • Fluency in English and German.
  • 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 with computer skills, such as 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 Caleb Mensah at +44 203 854 1080 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.