Supplier Quality Engineer

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.

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