BD (Becton, Dickinson and Company) Quality Engineer (m/f/d) New Product Development in Karlsruhe, Germany
Job Description Summary
About the Role
Responsible for supporting quality engineering activities during the development of new products (NPD) from concept through commercialization as part of a cross functional development team.
Current focus: Support component qualification activities.
Support Test Method Validation (TMV) activities related to inspection methods for manufacturing/assembly processes, test methods for components received at incoming inspection, and test methods for design verification and validation testing.
Performs statistical analysis to determine tolerance intervals, process capability, and statistical control limits, among others.
Support design verification and validations activities by reviewing protocols/reports and performing data integrity verification.
Support process qualification and validation activities (IQ, Ranging studies, OQ and PQ) by reviewing protocols/reports and performing data integrity verification.
Bachelor degree in an Engineering discipline, preferably Mechanical Engineering, process engineering, material sciences, chemical or pharmaceutical engineering.
Minimum 2 to 3 years experience in medical device industry or similar industrial environment with good working knowledge of regulatory requirements and Quality Systems.
Effective oral and written communication skills.
Good analytical capabilities. Process oriented with good attention to detail.
Ability to work in a multidisciplinary and international team environment.
Working experience with Minitab software.
Working knowledge of appropriate global medical devices regulation and standards, such as ISO 13485, ISO 14671, European Medical Device Regulation is a plus.
Fluent written and oral English; fluent written and oral German preferable.
Knowledge of the standard MS office software.
Experience in a similar position preferable.
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 Location