BD (Becton, Dickinson and Company) Principal Quality Engineer in Murray Hill, New Jersey
This position provides quality engineering support to the BDI Quality Assurance segment level staff and to Business units within the BDI segment as directed.
This position provides primary oversight and administration of the BDI quality management system, product root cause investigation review, and quality system integration between legacy Bard systems and global BD quality systems.
Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.
Review failure investigations/remedial action plans (RAPs) for product failures submitted by BDI business units and requiring Segment PAT approval.
Writes technical documentation to establish quality management systems, data analysis, and post market data tracking and trending.
Maintain an up to date knowledge in the areas of quality assurance, regulatory compliance, design controls, risk management, and statistical techniques.
Provide expertise in the areas of quality assurance, regulatory compliance, design controls, risk management, and statistical techniques.
Teaches Quality Engineering tools and monitors application to identify, asses and close gaps. Mentor employees and identify their training priorities, as directed by manager.
S. in Engr or Tech Science
7-10 years - relevant experience
Ability to effectively deal and negotiate with members of BD multi-functional Business Units and representatives of various government and regulatory agencies.
Ability to travel within the USA and internationally.
Must read, write and understand English. Must be exact in handling detailed information/data.
Strong working knowledge of ISO, Medical Device Directive, GMP/QSR and other applicable regulations.
Ability to present and communicate complex quality system information to management.
Working knowledge of how quality systems are created and maintained.
Ability to analyze complex data and apply statistics to make decisions.
S. in Engr or Tech Science preferred
Career Level: experienced
Division Name: BDI Corporate
Relocation Available?: No
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 730 Central Ave
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.