Senior Quality Engineer (m/w) Operations

Beschreibung

Aufgaben:
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

Jobtitel:
Senior Quality Engineer (m/w) Operations

Jobnummer:
38850

Stellentyp:
freiberuflich

Einsatzort:
D7

Starttermin:
asap

Dauer:
6 Monate +

Anforderungen:
- 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

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

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