BD (Becton, Dickinson and Company) Operations Quality Engineer (m/f/d) in Bruchsal, Germany
Job Description Summary
Risk 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 Location
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.