For one of our clients, we are looking for a Product Quality Engineer - QC.
The perfect candidate is a person with a very high level of quality awareness who enjoys working with a wide variety of interfaces in a large organization and for whom precise documentation is a matter of course. Technical know-how and knowledge of laboratory diagnostics are just as much a part of the skills as the ability to deal with stressful situations.
General Information:
* Extension: Highly probable
* Home Office: occasionally possible
* Travel: Minor travel (1x per 6 months)
* Department: Production Engineering
* Work Hours: Standard
Responsibilities:
* Ensuring and checking the product quality of the assigned products across the entire assembly and testing chain
* Technical approval of the assigned products and initiation of escalation in the event of defective products
* Processing and technical review of deviations (e.g. Q reports)
* Coordination of Q reports to handle supplier errors that have arisen during production
* Responsible for the evaluation and analysis of quality data and regular conduct of product quality meetings
* Creation, updating, review and training of specification documents, instructions and reports as well as technical review of validation and qualification documents
* Processing of specific CAPA and ECR tasks
* System owner of test stations, responsible for the calibration/maintenance of equipment and the creation of relevant documents
* Implementation of KVP (continuous improvement process) measures
Must haves:
* Either university or technical college degree in medical technology / mechanical engineering / comparable technical field or basic technical training (EFZ) in the field of toolmaking, polymechanics or similar with practical experience in quality assurance or in the diagnostic / molecular biology laboratory
* First professional experience in series production companies
* First professional experience in the field of quality assurance, quality technology, test planning (GxP environment)
* Practical experience in the regulated GxP environment, ideally medical technology or IVD (ISO 13485, FDA 21 CFR 820, IVDR / MDR)
* Very good communication skills in German and English (spoken and written) are required
Nice to haves:
* Practical experience in applying the Six Sigma methodology
* Experience in handling complaint and deviation reports
* In-depth IT knowledge (SAP; Tableau; statistical analytics)
* Strong stakeholder and expectation management in interdisciplinary teams
* Experience in a highly regulated production environment
* Expertise in molecular biology, especially sequencing
Seniority level
* Associate
Employment type
* Contract
Job function
* Quality Assurance and Engineering
Industries
* Staffing and Recruiting
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