Supplier Quality Engineer - MDR
SQE will 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 comply with the Medical Device Regulations.
- Technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements.
- Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
- Support definition and clarification of EU MDR supplier-related process requirements.
- Support Review and Approval of 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.
- A minimum of a bachelor's degree or equivalent in engineering or associated technical field is required.
- A minimum of 3 year's experience in quality engineering is required.
- A minimum of 2 year's experience in the medical device and/or pharmaceutical industry is required.
- Familiarity with ISO 13485 and FDA
- 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.