Supplier Quality Engineer

Global Medical Device Permanent 02.01.2019

I’m looking for a Supplier Quality Engineer for the largest, most innovative and comprehensive orthopedic and neurological business in the world. In this role the main responsibility is to ensure that all externally manufactured products meet the new EU MDR requirements. They are looking for permanent members in 3 locations: Leads, Cork and Zürich.

I’m looking for a Supplier Quality Engineer for the largest, most innovative and comprehensive orthopedic and neurological business in the world. In this role the main responsibility is to ensure that all externally manufactured products meet the new EU MDR requirements. They are looking for permanent members in 3 locations: Leads, Cork and Zürich.
RESPONSIBILITIES

  • You will evaluate the supplier’s manufacturing process information, production risk management, direct part marking documentation against MDR Requirements
  • You will collaborate with the supplier to revise existing or develop new manufacturing process information, production risk management and/or direct part marking documentation as applicable
  • You will support project deliverables; meeting project timelines; resolving identified supplier issues and executing the overall project related to technical file remediation requirements.
  • You will assess supplier drawings and process information to support project deliverables
  • (Manufacturing Process Information, Production risk management file, Validation protocols and reports, Direct part marking documentation)
  • You will work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
  • You will cross coordinate Workstream activities/interdependencies with other workstream and project teams.
  • You will support Review and Approval of supplier Process Validation Protocols and Reports as applicable.
  • You will support the update of supplier related Inspection Criteria as applicable.

PROFILE

  • Bachelor’s degree or equivalent in engineering or associated technical field
  • A minimum of 3 years’ experience in a quality engineering
  • A minimum of 2 years’ experience in the medical device and/or pharmaceutical industry
  • Familiarity with ISO 13485 and FDA QSR
  • Excellent organizational skills and attention to detail
  • Ability to work independently and prioritize with limited supervision.
  • Strong written and oral communication and interpersonal skills.
  • Excellent computer, communication, and written skills are required
  • Proficiency in Microsoft Office suite

START DATE

January 2019

INTERESTED?

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.

For further information, please contact Nora Bede at +31 (0)20 20 44 502 or by email at n.bede@panda-int.com

PANDA INTERNATIONAL is a specialist recruitment agency dedicated to placing high-level candidates in freelance and temporary roles within the Pharmaceutical, Medical Device, Biotech and Food sectors across Europe. By working closely with candidates and companies in meeting challenging business demands, the Panda team has developed an extensive client base consisting of the world’s leading Life Sciences organizations.

 

 

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