- Support in Implementation and improving of development processes (Design Controls)
- Leading and supporting problem-solving-activities with e.g., root-cause-analysis and other methods and tools
- Reviewing and providing feedback on Release deliverables.
- Providing quality engineering support during development and sustaining of new product designs and production processes ensuring regulatory compliance and adherence to QMS requirements.
- Supporting CAPAs
- Regulatory and compliance assessments and follow-up-support.
- Tracking of KPIs
- Bachelor, or Master degree in engineering
- 3 to 5 years' experience in software development
- Working within a Quality system (ISO 9001, ISO 13485, IATF 16949, etc.)
- Software development and testing (C#, C++, Java, etc.)
- Experience in an agile environment is a plus
- Technical understanding
- Working in an engineering manner
- Independent and initiative-taking working
- Strong quality awareness and attentiveness to details
- Professional working in interdisciplinary teams
- Communication in German and English
- Software testing
- Risk Management (FMEA)
- Problem Solving (e.g., 8D)
- DFSS-methods and tools
- Analytical software such like Minitab
- MS-Office (Word, Excel, Outlook, ...)
- GMP/GaMP is a plus
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BD (Becton, Dickinson and Company) Columbus, United StatesJob Description Summary · Avec plus de 70000 collaborateurs dans le monde, des talents, des savoir-faire au service de la santé, un marché en forte expansion, BD, fabricant et distributeur de dispositifs médicaux et de matériels de diagnostic est une référence incontournable du m ...
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Project Electro-Mechanical Technician 1st Shift - Columbus, United States - BD (Becton, Dickinson and Company)
Description
Job Description SummaryWe are flexible This position can be either full time or part time based on need and individual agreement.
Job Description
The Quality Engineer, Software, is supporting the Associate Director Quality Management for implementing, improving, and monitoring processes and tools to ensure an elevated level of quality of the design of our products.
The holder of this position takes care that during the whole design process and lifecycle of the product all applicable quality elements (Requirements Engineering, Risk Management, Design Validation and Verification) are utilized by the development teams.
In cooperation with the Regulatory function the Quality Engineer, Software, makes sure, that the teams deliver designs which are compliant to applicable standards and legislations.
About the RoleKnowledge and skills:
A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs.
In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.
Primary Work LocationDEU Kelberg - Rowastrasse
Additional Locations
Work Shift
