Beschreibung
Wir suchen ab sofort für unseren Kunden einen Interim Quality Engineer (w/m/d) in Vollzeit für ca. 12 Monate mit Option auf Verlängerung am Standort Raum Hamburg.
Einsatz: ca. 50% vor Ort & 50% Remote Work möglich
- Validation of a defined article group related to different processes
Preparation of full documentation: VP, Study (if necessary), IQ, TMV (if necessary), OQ, PQ, VR
- Controls and support control of the quality of the entire article group starting from the VP preparation until the implementation in to the QMS system.
- Acts as part of a defined team
- Execution of all relevant validation activities (see no. 1) acc to SOPs
- Provides solutions / improvement activities
- Performs test process validation and equipment qualification activities
- Specifies and qualifies test equipment
- To perform in this job role successfully, an individual must be able to perform the essential duties satisfactorily. The requirements listed below are representative for the education, knowledge, skill and/or ability required.
- Some years of experience in a regulated and high industrial production environment
- ISO 13485 / ISO / FDA / Medical technology background
Einsatz: ca. 50% vor Ort & 50% Remote Work möglich
- Validation of a defined article group related to different processes
Preparation of full documentation: VP, Study (if necessary), IQ, TMV (if necessary), OQ, PQ, VR
- Controls and support control of the quality of the entire article group starting from the VP preparation until the implementation in to the QMS system.
- Acts as part of a defined team
- Execution of all relevant validation activities (see no. 1) acc to SOPs
- Provides solutions / improvement activities
- Performs test process validation and equipment qualification activities
- Specifies and qualifies test equipment
- To perform in this job role successfully, an individual must be able to perform the essential duties satisfactorily. The requirements listed below are representative for the education, knowledge, skill and/or ability required.
- Some years of experience in a regulated and high industrial production environment
- ISO 13485 / ISO / FDA / Medical technology background