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