Product Quality Engineer - QC
Date de publication :
13 février 2025Taux d'activité :
100%- Lieu de travail :Rotkreuz
Résumé de l'emploi
Nous recherchons un Ingénieur Qualité Produit pour un client. Rejoignez une équipe dynamique offrant des opportunités d'évolution.
Tâches
- Assurer la qualité des produits tout au long de la chaîne.
- Approuver techniquement les produits et initier des escalades si nécessaire.
- Analyser les données qualité et organiser des réunions régulières.
Compétences
- Diplôme en technologie médicale ou domaine similaire requis.
- Excellentes compétences en communication en allemand et anglais.
- Expérience pratique en environnement GxP requise.
Résumé de l'annonce originale
Est-ce utile ?
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:
- Start date: ASAP
- Latest start date: June 2025
- Planned employment duration: One-year contract
- Extension: Highly probable
- Location: Rotkreuz
- Workload: 100%
- 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