BD (Becton, Dickinson and Company) Operations Quality Engineer (m/w) in Karlsruhe, Germany
Job Description Summary
BD ist ein international tätiges MedTec-Unternehmen, das den Fortschritt für die Welt der Gesundheit vorantreibt.
BD Interventional bietet Lösungen für den OP und die sterile Aufbereitung mit dem letztendlichen Ziel, das Leben von Patienten zu verbessern. Unser Augenmerk liegt u.a. auf die Herstellung von innovativen minimal-invasiven sowie medizin-technischen Produkten und Dienstleistungen in den Bereichen Urologie, Gynäkologie, Onkologie, Hernienchirurgie und Gefäßmedizin.
Für unseren Standort in Bruchsal suchen wir zeitnah einen Operations Quality Engineer (w/m) für die Produktion von Gefäßimplantaten.
The Operations Quality Engineer (m/w) will participate in day to day quality operations activities to ensure conforming materials are available for manufacturing and to provide quality reports for ongoing process monitoring and improvement. Plus, he will perform timely disposition of non-conforming materials identified in Incoming Quality Control or during the in-house manufacturing processes to ensure continued material compliance.
Additional to that the OQE:
Works 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.
Builds and maintains relationship with critical component suppliers, to ensure responsiveness and high quality materials from the supply chain. Responsible for communication with vendors for quality related matters pertaining to materials or components supplied and services provided.
Ensures development of specifications and inspection/test methods for evaluation of materials required in routine manufacturing.
Responsible for disposition of non-conforming product identified during inspection to pre-established specifications for incoming materials, sub-assembly components and finished products.
Responsible for participating in corrective/preventive action activities, applies root cause analysis and problem solving techniques.
Responsible for performing risk assessment activities, generating material specifications and inspection procedures and for supporting validation activities relating to design to manufacturing transfers, process changes and non-conformance investigations.
Supports change control activities, including QA assessment as part of change management activities.
Supports R&D and Operations teams to develop and maintain risk assessment / risk controls and supports investigation and disposition of non-conforming products and investigations of manufacturing or supplier related complaints.
Supports cost improvement and lean activities per applicable project plan.
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.
Diversity: Angiomed is an affirmative action, equal opportunity employer and actively seeks diversity in it`s workforce.
Working in a highly motivated team in a global environment. A family atmosphere in an innovative environment where your opinion counts. A secure job with long-term prospects. We also offer capital formation benefits and company benefits (according to length of service). 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:
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.