Senior Quality Engineer (m/w) Operations

Aktuell sind wir auf der Suche nach einem Senior Quality Engineer (m/w) Operations.

Ihre Aufgaben:
+ Ensures compliance to quality system requirements as defined by MCP procedures, FDA QSR and applicable international and national standards (e.g. ISO, IEC, ASTM)
+ Applies risk management, change control and valid principles throughout the product lifecycle
+ Supports the engineering change process
+ Reviews and approves first article inspection reports
+ Develops inspection plans for series production
+ Supports development of reviews and approves design verification & validation test protocol and reports
+ Supports development of reviews and approves process validation protocols and reports
+ Decides timely on the disposition of non-conforming materials to ensure continued material compliance. Executes and communicates product holds and releases
+ Works on non-conformance and CAPAs
+ Supports the creation of risk assessments related to quality issues
+ Resolves quality issues associated with the design or the manufacturing processes of the product
+ Performs supplier audits and supports the supplier qualification process
+ Issues Supplier corrective Action Requests and reviews the suppliers response
+ Supports development of appropriate product/component specifications
+ Supports development of inspection/test methods. Reviews and approves test method validation protocols and reports

+ Engineering degree required (e.g. electrical, biomedical, mechanical or process engineering, material sciences, aerospace industry, automotive engineering)
+ Min. 3 years experience in the medical device industry or similar industrial environment with good working knowledge of regulatory and quality system requirements
+ Experience in risk-based decision making and systematic root cause identification techniques
+ Good analytical capabilities
+ Knowledge of design validation and change control principles and techniques
+ Ideally, knowledge of statistical methods and Six Sigma tools
+ Knowledge of IEC 60601
+ Knowledge of risk management principles and techniques (ISO 14971)
+ Knowledge of project management fundamentals and tools
+ Computer systems skills (MS Office software, statistical software)
+ Good teamwork capabilities, effective reporting
+ Fluent German and good English communication skills

Wenn wir Ihr Interesse wecken konnten freuen wir uns über die Zusendung Ihres aussagekräftigen Profils unter Angabe Ihrer Verfügbarkeit und Ihres Stundensatzes.