Job Opportunities in Switzerland
May 28, 2024
ITech Consult
Rotkreuz
FULL TIME
Product Quality Engineering
Product Quality Engineering (m/w/d)
Product Quality Engineering (m/f/d) - Series production/ Quality Assurance/ Quality engineering/ Test planning / Gx P / Medical technology or IVD (ISO 13485, FDA 21 CFR 820, IVDR/MDR)/ English/ German
Project :
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a Product Quality Engineering (m/f/d)
Background :
Instrument Operations Rotkreuz ensures the production and management of a complex portfolio of small to large analysis systems. Within this organization, the Production Engineering department is a support department with 6 different teams that support assembly, quality control, technical release and packaging of the diagnostic devices. Our goal is to provide the best possible support for production in order to ensure smooth processes and the highest quality and quantity. As one of these 6 teams, the QC Product Quality Engineers are responsible for ensuring and checking product quality.
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.
Tasks & 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 for the processing of supplier errors that have arisen during production
* Responsible for the evaluation and analysis of quality data and regular implementation 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 is an advantage.
* First professional experience / at least 1 year of professional experience in series production companies
* First professional experience / at least 1 year of professional experience in the field of quality assurance, quality technology, test planning (Gx P environment)
* Practical experience in the regulated Gx P 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 Have:
* Practical experience in the application of 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
Reference Nr.: 923452SDA
Role: Product Quality Engineering
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 50-60%
Start: 01.07.2024
Duration: 12++
Job Type: 100%
Schedule:
Product Quality Engineering (m/f/d) - Series production/ Quality Assurance/ Quality engineering/ Test planning / Gx P / Medical technology or IVD (ISO 13485, FDA 21 CFR 820, IVDR/MDR)/ English/ German
Project :
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a Product Quality Engineering (m/f/d)
Background :
Instrument Operations Rotkreuz ensures the production and management of a complex portfolio of small to large analysis systems. Within this organization, the Production Engineering department is a support department with 6 different teams that support assembly, quality control, technical release and packaging of the diagnostic devices. Our goal is to provide the best possible support for production in order to ensure smooth processes and the highest quality and quantity. As one of these 6 teams, the QC Product Quality Engineers are responsible for ensuring and checking product quality.
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.
Tasks & 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 for the processing of supplier errors that have arisen during production
* Responsible for the evaluation and analysis of quality data and regular implementation 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 is an advantage.
* First professional experience / at least 1 year of professional experience in series production companies
* First professional experience / at least 1 year of professional experience in the field of quality assurance, quality technology, test planning (Gx P environment)
* Practical experience in the regulated Gx P 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 Have:
* Practical experience in the application of 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
Reference Nr.: 923452SDA
Role: Product Quality Engineering
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 50-60%
Start: 01.07.2024
Duration: 12++
Job Type: 100%
Schedule:
- 8 Hour Shift
We regret to inform you that this job opportunity is no longer available
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