The incumbent will be responsible for combining Design control expertise, creative problem-solving approaches and strong analytical skills to support new product development and product maintenance using Quality Engineering skills (e.g.: risk management, measurement system analysis, root cause analysis, etc).
The position requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
Assist/conduct Failure Investigations and problem solving sessions for non-conforming products
Consistent application of technical principles, theories, concepts and quality sciences / tools
Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
Contributes to the completion of specific programs and projects
Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
Independently determines and develops approach to solution
May provide guidance and work direction to other team members
Designs and performs development working independently within defined parameters with minimal supervision required
Liaise with Manufacturing Plants
Provide functional support to cross-functional teams
Provide Quality engineering support to all assigned projects, manufacturing facilities and suppliers.
Function as a Quality Core Team Representative on Design/Development and Manufacturing project teams.
Ensure Design Control Elements are satisfied.
Design History File support
Design Verification plans, protocols, and reports
Bachelor Degree in Engineering, Science or related field
12+ years of Quality Engineering experience in the medical device industry
Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards
Expert knowledge of design control principles
Experience with electromechanical device and device software standards and requirements required
Thorough understanding of Statistical Methods for Quality Assurance
Good written and oral communication skills
Excellent problem solving and analytical skills
Ability to handle multiple projects simultaneously in an unsupervised environment
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.
Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.