• Contract
  • Zurich/Zug
  • Recruiter: Anil Dahiya

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Quality Engineer – 5108 ADA

 

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Quality Project Engineer on contract basis starting from 02.01.2023 until 31.12.2023 with an option of extension based in Central Switzerland.

Project Goal: To ensure all externally manufactured company’s products meet new EU MDR requirements.

Collaborate with suppliers to obtain details for manufacturing process information, production risk management, process controls, validation and direct part marking. This information will be used to update the product’s technical file to be in compliance with Medical Device Regulations. EU MDR SQE will work under the direction of the EU MDR SQ project supervisor.

Deliverables: The EU MDR SQE will evaluate the supplier’s manufacturing process information, production risk management, process controls, validation and direct part marking documentation against MDR Requirements; collaborate with the supplier to revise existing or develop new manufacturing process information, production risk management, process controls, validation and/or direct part marking documentation as applicable.

 

Main Responsibilities:

  • Become a working member of the technical file remediation efforts to ensure externally manufactured company’s 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.
  • Assess supplier drawings and process information to support project deliverables:
  • Manufacturing Process Information and Controls
  • Production risk management file
  • Validation protocols and reports
  • Direct part marking documentation: 2D barecode implementation, etching validation and TMV.
  • Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
  • Cross coordinate Workstream activities/interdependencies with other workstream and project teams.
  • Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities;
  • Support definition and clarification of EU MDR supplier related process requirements.
  • Support Review and Approval EU MDR Change Projects as applicable.
  • Support Supplier Quality Functional Impact Assessments as applicable.
  • Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.
  • Support the update of supplier related Inspection Criteria as applicable.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • A minimum of a bachelor’s degree or equivalent in engineering or associated technical field is required.
  • A minimum of 3 years’ experience in a quality engineering is required.
  • A minimum of 2 years’ experience in the medical device and/or pharmaceutical industry is required.
  • Three years’ experience as Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or equivalent role within regulated industry.
  • Familiarity with ISO 13485 and FDA QSR is required. Excellent organizational skills and attention to detail is required.
  • Understanding supplier management and 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
  • Must be able to work independently and prioritize with limited supervision.
  • Strong written and oral communication and interpersonal skills. Excellent computer, communication, and written skills are required. Proficient in Microsoft Office suite is required.

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