Design Quality Engineer (m/w/d)

REFERENZNUMMER:

409205/11

MEINE AUFGABEN:

-Design Quality team member focused on life cycle management activities
-Review of Techfiles or Technical Documentation of DHF
-Riskfiles and Documentation DIOVV
-GAP documentation
-Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement
-Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes
-Perform Gage R&R studies
-Conduct and lead design verification and validation activities
-Conduct and lead design / process failure mode effects and analysis
-Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
-Provide leadership in the understanding of medical device regulations to other disciplines
-Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing
-Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times
-Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations
-Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans

MEINE QUALIFIKATIONEN:

-A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a in-depth experience in related field is required
-Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required
-Previous Quality Engineering experience is preferred
-Experience in an Medical Device regulated environment
-Strong knowledge and skills in MS Office
-Excellent problem solving, decision-making, and root cause analysis skills are required
-Interpersonal skills that foster conflict resolution are required
-Ability to multi-task independently with minimal supervision
-Development and manufacturing experience is preferred
-Fluency in English is required, good knowledge of German would be a strong asset

MEINE VORTEILE:

-You will work in an international environment
-A very renowned company
-A highly motivated team and an open way of communication

PROJEKTINFORMATIONEN:

-As a modern company, our client manages to constantly develop further and break new ground

ÜBER HAYS:

Mit über 15 Jahren Erfahrung in der klassischen Pharmaindustrie ebenso wie in der Biotechnologie und Medizintechnik kennen wir die entscheidenden Ansprechpartner, die anspruchsvolle Aufgaben mit Potenzial ausschreiben. Die hohe Personalnachfrage eröffnet spannende Möglichkeiten für engagierte Experten, um sich beruflich zu entwickeln und an ihrer Karriere zu arbeiten. Ihnen als Kandidat bieten wir dabei als spezialisierte Personalberatung mit einem internationalen Netzwerk entscheidende Vorteile – und das völlig kostenfrei für Sie. Registrieren Sie sich und profitieren Sie von interessanten und passenden Positionen und Projekten.

MEIN KONTAKT BEI HAYS:

Mein Ansprechpartner
Sevda Karakas

Referenznummer
409205/11

Kontakt aufnehmen
E-Mail: [email protected]