Product Quality Engineer - QC

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