Supplier Quality Engineer

CK Group
80 CHF per hour
26 Nov 2020
24 Dec 2020
Adrien Guimard
Contract Type
Full Time
CK QLS are recruiting for a Supplier Quality Engineer to join a company in the Pharmaceutical industry at their site based in Solothurn on a contract basis for a 12 month contract.

Supplier Quality Engineer Role:

Your responsibilities will include:
  • Becoming a working member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements, including supporting project deliverables; meeting project timelines; resolving identified supplier issues and executing the overall project related to technical file remediation requirements.
  • Assessing supplier drawings and process information to support project deliverables such as Manufacturing Process Information and Controls, Production risk management file, validation protocols and reports, Direct part marking documentation
  • 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.

Further responsibilities include:
  • Definition and clarification of EU MDR supplier related process requirements.
  • Review and approval EU MDR Change Projects as applicable.
  • Supplier Quality Functional Impact Assessments as applicable.
  • Review and approval of supplier Process Validation Protocols and Reports as applicable.
  • To support the update of supplier related Inspection Criteria as applicable.

Your Background:
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
  • A minimum of a bachelor's degree or equivalent in Engineering or associated technical field is required.
  • Experience in a quality engineering is required.
  • Experience in the medical device and/or pharmaceutical industry is required.
  • Familiarity with ISO 13485 and FDA QSR is required.
  • Excellent organizational skills and attention to detail is required. Must be able to work independently and prioritize with limited supervision.
  • Strong written and oral communication and interpersonal (listening) skills.
  • Excellent computer, communication, and written skills are required.
  • Proficient in Microsoft Office suite is required.
  • Fluent in English, German is an advantage.

For more information or to apply for this Supplier Quality Engineer position, please contact CK Group, quoting job ref 49364.

Thanks for sending all documents needed such as CV, cover letter, reference letters, degree and relevant certificates along with your application. Please could you send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

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