Senior Quality Engineer (m/f)

REFERENZNUMMER:

303028/1

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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)

WEITERE QUALIFIKATIONEN:

Quality manager