Job Description Summary
The Quality Systems Engineer supports the Manager, Quality Systems, to ensure compliance to quality systems requirements as defined by BD Corporate and Business Unit, FDA QSR, ISO 13485, and other applicable standards and regulations through the implementation and maintenance of effective quality systems.
We are flexible! This position can be either full time or part time according to need and individual agreement.
Job Description
We are the makers of possible!
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
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Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us!
Key responsibilities:
• Assists in the establishment of effective quality systems via documented procedures, training, and verification / audit of systems effectiveness.
• Assures the effective evaluation, trending, and reporting of quality performance indicators.
• Maintains effective reporting systems to support the management reviews and to allow implementation of corrective/preventive actions.
• Supports effective management of quality system improvement projects assigned.
• Provides engineering and systems support to the Event Review and CAPA system.
• Assures the trending and evaluation of quality events through the CAPA source data trending tool.
Further responsibilities:
• Investigation and analysis of incoming customer complaints in accordance with the principles and methods of quality management and within the framework of existing procedures and regulations.
• Evaluation of incoming information regarding product functionality and safety by applying and continuing to develop statistical methods.
• Supporting the safety officer in meeting regulatory requirements for laboratory management
• Provides engineering and systems support to the Post Market Surveillance program.
• Supports during preparation and conduct of 3rd party audits.
• Supports and provides resources for the internal audit management.
About You:
• 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).
• Preferred work experience in the medical device industry.
• Knowledge in risk-based decision making and problem-solving.
• Good analytical capabilities.
• Well-developed capacity for logical and abstract thinking.
• Knowledge of failure investigation method/problem solving techniques
• Knowledge of project management fundamentals and tools.
• Knowledge of risk management principles and techniques and root cause analysis tools.
• Good computer skills (MS Office products, database applications)
• Fluent English communication skills (business English written and oral).
• Good understanding of/experience with US business culture and communication style.
• Ability to work in a team.
• Ability to prioritize tasks and handle multiple tasks simultaneously.
Our Offer:
• Working in a global organization with highly motivated teams
• An innovative company with an environment where your input counts
• Office-/home-based position in Karlsruhe
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
To learn more about BD visit: https://bd.com/careers
Primary Work Location
DEU Karlsruhe
Additional Locations
Work Shift