Quality Engineering

* Approval of quality documentation and records
* Product release and recall
* Coordination of validation activities on site
* Coordination of test method development and validation
* Corrective and preventive actions, Non-conformities
* Complaint handling
* Optimize processes and related process interfaces
* Internal and supplier auditing
* Create specifications and technical information, updating the technical documentation
* Application of harmonized standards
* Create quality templates
* Supporting R&D projects and approving Design Control documentation
* Chair / participate in design reviews and release product/processes within design reviews
* Act as risk management owner
* Generate Risk Analyses and/or participate in risk management teams
* If required, the senior QE can act as representative QMB
* If required, the senior QE can act as safety officer as per §30 MPG
* The Senior Quality Engineer will be backup for the functions of Quality engineering and Quality Assurance (QS)

VORAUSSETZUNGEN:

* QMS training as per F 622-1-015 Schulungsmatrix
* Knowledge of ISO 13485, ISO 14971, German MPG und 93/42/EEC, CFR
* Engineering/Science qualification preferred Knowledge of statistical techniques and quality improvement tools
* At least 5 years work experience in a medical device environment
* At least 3 years work experience in a quality and/or regulatory work environment
* Ability to work well under pressure
* Attention to detail and accuracy
* Good German and English, both written and oral
* Problem solving skills for developing creative solutions and meeting objectives are required.
* Excellent analytical ability

EINSATZBEREICHE:

Anlagenbau, Ingenieurwesen/Technik, Maschinenbau, Ingenieurwesen/Technik, Sonstiges