Description
We are looking for a
Supplier Quality Engineer (m/f)
Reference: -en
Start: asap
Duration: 3 MM++
Place: in Bavaria
Branch: Medizintechnik
Your tasks:
- Interface with supplier‘s engineering and quality organizations
- Drive corrective and preventive actions at the supplier to preclude recurrence of identified issues
- Perform direct and indirect supplier evaluations
- Implement supplier risk analysis and mitigation plans
- Maintain and monitor Approved Supplier List
- Control plans that define the supplier’s processes and identify areas of risk
- Review and approve engineering design changes and supplier change requests to determine part requalification needs
- Develop supplier’s knowledge and implementation of quality tools and techniques
Your qualifications
- Bachelor of Science in Engineering
- Electrical/Electronic engineering knowledge preferred
- Profound quality assurance and/or engineering experience preferred
- Experience with US medical device regulations (21 CFR Parts 820, 803, and 806)
- Experience with standard quality system requirements (ISO 9001, EN ISO 13485, Medical Device Directive, Canadian Medical Device Regulation)
- Supplier quality experience in medical device
Skills:
- Quality manager