Summary of Position with General Responsibilities
- 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.
Essential Job Functions
- 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.
Additional Desirable Qualifications Skills and Knowledge
- S. in Engr or Tech Science preferred
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