Quality Engineer

☞ Proclinical Staffing

View: 162

Update day: 25-04-2024

Location: Zug Zug ZG

Category: Quality Assurance / Quality Control

Industry: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Position: Entry level

Job type: Contract

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Job content

Proclinical are recruiting a Quality Engineer for a medical device corporation. This role is on a contract basis and is located in Zug. The client is focused on delivering novel solutions to address unmet needs of the healthcare of patients.

Responsibilities
  • Collaborate with suppliers to meet the needs of EU MDR and produce solutions relating to Supplier Product Information.
  • When appropriate, you will be supporting supplier quality functional impact evaluations.
  • To guarantee externally produced company products meet the needs of EU MDR, you will become a working member of the technical file remediation efforts. This involves assisting with project deliverables; meeting project deadlines; solving recognised supplier matters and implementing the general project correlated to technical file remediation necessities.
  • When relevant, you will assist with analysing and consenting to supplier Process Validation Protocols and Reports.
  • When valid, you will support the update of supplier associated Inspection Criteria.
  • You will cross organise Workstream activities/interdependencies with all other workstream and project teams.
  • Collaborate with Supply Chain to assist EU MDR provider interactions and rollout of EU MDR Supply Chain Workstream doings.
  • The ideal candidate will assist with outlining and recognising the needs of EU MDR supplier linked processes.
  • You will support the analysis and sanction of EU MDR Change Projects when pertinent to do so.
  • Evaluate supplier sketches and procedure material to assist in project deliverables: Manufacturing Process Information and Controls of Production risk management file; Validation procedures and reports of Direct part marking papers.
Skills & Requirements
  • At least educated to a Bachelor’s degree level or similar within an engineering or related technical discipline.
  • At least 3 years of experience in a quality engineering role.
  • At least 2 years of experience in the medical advice and/or pharmaceutical industry.
  • Acquaintance with ISO 13485 and FDA QSR.
  • Exceptional organisational skills with a high attention to detail and the ability to operate independently and prioritise tasks with minimal supervision.
  • Solid communication (both written and verbal) skills as well as social skills.
  • Brilliant computer skills.
  • Microsoft Office suite literate.
  • Fluency in the English language; fluency in the German language would be advantageous.
  • At least 3 years of previous experience as a Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or in a similar position within regulated industry.
  • Strong comprehension of supplier management and validation processes and implementation.
  • Sturdy background knowledge in Medical Device Regulatory Compliance/Regulatory Affairs.
  • Former experience collaborating with suppliers across numerous locations and franchises.
  • Capable of acting as an SME in a supplier business procedure.
  • Prior experience with medical device technical files.
If you are having difficulty in applying or if you have any questions, please contact Mohammed Alli at +41 61 568 79 85.

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

Proclinical Staffing is an equal opportunity employer.

#Scientific

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Deadline: 09-06-2024

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