Description
We are looking for a
Senior Quality Engineer (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:
- Ensure compliance to quality system requirements as defined by clients' procedures, FDA QSR and applicable international and national standards (e.g. ISO, IEC, ASTM)
- Apply risk management, change control and valid principles throughout the product lifecycle
- Support the engineering change process
- Review and approve first article inspection reports
- Develop inspection plans for series production
- Support development of reviews and approve design verification & validation test protocols and reports
- Decide timely on the disposition of non-conforming materials to ensure continued material compliance
- Execute and communicate product holds and releases
- Support the creation of risk assessments related to quality issues and work on non-conformance and CAPAs
- Resolve quality issues associated with the design or the manufacturing processes of the product
- Perform supplier audits and supports the supplier qualification process
- Support development of appropriate product/component specifications and inspection/test methods
- Review and approve test method validation protocols and reports
Your qualifications
- Engineering degree (e.g. electrical, biomedical, mechanical or process engineering, automotive engineering)
- Experience in the medical device industry or similar industrial environment with good working knowledge of regulatory and quality system requirements
- Experience in risk-based decision making and systematic root cause identification techniques
- Knowledge of design validation and change control principles and techniques
- Knowledge of IEC 60601 and of risk management principles and techniques (ISO 14971)
Skills:
- Quality manager