Die KI-Suchmaschine für Jobs
Design Assurance Engineer Medical Devices(m/w/x)
Design Control document review for engineered components in healthcare, ensuring MDR/CFR820 compliance and risk management. 2+ years professional experience with product quality in a highly regulated industry required. Direct involvement in product lifecycle from design to market.
Anforderungen
- Completed technical and/or physical studies
- At least 2 years of professional experience
- Experience with product quality in a highly regulated industry
- Experience in theory and application of quality methods and techniques
- English fluency
- German language skills would be a plus
- Quality-consciousness
- Trustworthiness
- Reliability
- Team player
- Good communication skills
- Structured and systematic way of working
Aufgaben
- Create an overall quality plan
- Review design verification and validation specifications
- Review test specifications and reports for medical devices
- Review Design Control documents according to GDP and MDR 2017/CFR820
- Lead and contribute to risk management activities
- Participate in FMEA and other quality assurance tasks
- Support the creation of a document plan and overall VnV plan
- Contribute to risk management content throughout product development
- Review the completeness of risk analysis
- Evaluate risk-reducing measures for severity and probability
- Create and review evidence for implementation of measures
- Prepare test specifications and requirements for series testing
- Participate in process synchronization and improvement measures
- Conduct failure analysis for field returns and during development
- Ensure compliance with quality, safety, and environmental regulations
Berufserfahrung
- 2 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Noch nicht perfekt?
- W.O.M. World of Medicine GmbHVollzeitnur vor OrtBerufserfahrenBerlin
- W.O.M. World of Medicine GmbH
Mechnical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Systems Engineer Disposables(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - Personalvermittlung Wanka
Qualitätsingenieur(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin
Design Assurance Engineer Medical Devices(m/w/x)
Design Control document review for engineered components in healthcare, ensuring MDR/CFR820 compliance and risk management. 2+ years professional experience with product quality in a highly regulated industry required. Direct involvement in product lifecycle from design to market.
Anforderungen
- Completed technical and/or physical studies
- At least 2 years of professional experience
- Experience with product quality in a highly regulated industry
- Experience in theory and application of quality methods and techniques
- English fluency
- German language skills would be a plus
- Quality-consciousness
- Trustworthiness
- Reliability
- Team player
- Good communication skills
- Structured and systematic way of working
Aufgaben
- Create an overall quality plan
- Review design verification and validation specifications
- Review test specifications and reports for medical devices
- Review Design Control documents according to GDP and MDR 2017/CFR820
- Lead and contribute to risk management activities
- Participate in FMEA and other quality assurance tasks
- Support the creation of a document plan and overall VnV plan
- Contribute to risk management content throughout product development
- Review the completeness of risk analysis
- Evaluate risk-reducing measures for severity and probability
- Create and review evidence for implementation of measures
- Prepare test specifications and requirements for series testing
- Participate in process synchronization and improvement measures
- Conduct failure analysis for field returns and during development
- Ensure compliance with quality, safety, and environmental regulations
Berufserfahrung
- 2 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Über das Unternehmen
W.O.M. World of Medicine GmbH
Branche
Healthcare
Beschreibung
The company creates engineered components and sub-systems for healthcare and advanced manufacturing, enhancing productivity and precision.
Noch nicht perfekt?
- W.O.M. World of Medicine GmbH
Mechanical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Mechnical Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Systems Engineer Disposables(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - Personalvermittlung Wanka
Qualitätsingenieur(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin