Supplier Quality Engineer

Highly Competitive
  1. Contract
  2. Good Manufacturing Practice (GMP)
  3. Switzerland
Solothurn, Switzerland
Posting date: 15 Mar 2021

An exciting opportunity has arisen for a Supplier Quality Engineer to collaborate with suppliers to obtain details for manufacturing process information, production risk management, process controls, validation and direct part marking. This is a contracted role in Switzerland, for a talented Quality Engineer.

Job Responsibilities

  • Become a working member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR 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
  • 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.

Skills and Requirements

  • 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.
  • Familiarity with ISO 13485 and FDA QSR is required.
  • Excellent organisational skills and attention to detail is required. Must be able to work independently and prioritise 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.
  • 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.

To Apply

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