Description
We are looking for a
Quality Assurance Expert (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Baden-Württemberg
Branch: Herstellung von medizintechnischen Apparaten und Materialien a. n. g.
Your tasks:
- design control
- Design transfer
- Process validation
- supplier qualification procedure
- Labeling, Packaging
- approvals in general
- other QM procedures related to new product development
- Review and approve Transfer from the developing Maquet Business Unit to the maintaining and selling Maquet business unit
- Conduct Supplier audits and approve suppliers including all documentation
- Create incoming goods inspection protocols and document (including reference in SAP)
- List critical components and their requirements for tracing
- Identify critical parts that require a special incoming good inspection
- Review and approve test specifications in production for new product and spare parts
- Review and approve process validation
- Review and approve Design Transfer Plan and corresponding tasks
- Review and approve production specification
Your qualifications
- 21 CFR 820 (Experte)
- ISO 13485 (Experte)
- SAP (nice to have)
- English fluent
Skills:
- Quality manager