Operations Quality Engineer (m/f/d)
Job Description SummaryRisk management, documenation and PMS activities due to EU-MDR requirements.
About the role
- Ensures that Angiomed complies with and adheres to all applicable quality system requirements during the manufacture and distribution of its medical devices.
- Utilizes quality engineering principles and techniques to ensure that products developed and manufactured by Angiomed consistently meet applicable performance standards and regulatory requirements.
- Supports manufacturing and design to manufacturing activities to ensure all products meet the applicable quality standards and regulatory requirements.
- Applies risk management, change control and validation principles throughout the product lifecycle.
- Applies and improves procedures for consistent and effective implementation of quality system and regulatory requirements in the area of responsibility.
- Working closely with manufacturing supervisors and operations management to improve current quality operations processes and to implement effective systems which are compliant with applicable quality and regulatory requirements.
- Supports quality system improvements for effective implementation of quality system and regulatory requirements and to streamline production and process control processes.
- Engineering degree required (e.g. in one of the following or similar areas: mechanical engineering, process engineering, material sciences, aerospace industry, automotive engineering, chemical or pharmaceutical engineering).
- 3 year industry experience in medical device industry or similar industrial environment (areas see above) with good working knowledge of regulatory requirements and quality systems techniques.
- Experience in risk-based decision making and problem solving.
- Good analytical capabilities.
- Knowledge of statistical methods and Six Sigma process excellence tools.
- Knowledge of risk management principles and techniques.
- Knowledge of root cause analysis and CAPA tools.
- Advanced computer system skills (MS office software, databases and statistical software).
- Good teamwork capabilities and effective reporting.
- Fluent communication in German and English (oral and written).
- Work environment: Job holder must be able to work in a team-oriented, fast paced environment. Good understanding of U.S. business culture and communication style.
Working in a highly motivated team in a global environment. A family atmosphere in an innovative environment where your opinion counts. A secure workplace with long-term prospects. We are very anxious for a long-term cooperation - a common career planning along different phases of life is therefore very important to us.
Are you interested in a career at BD, but this position does not match your skills and expectations? Then join our external EMEA Talent Community now: http://bd.tal3nt.community/
Primary Work LocationDEU Karlsruhe
Additional LocationsDEU Bruchsal
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