This position acts as a key leader for managing the project roll out to Production, for new products and new or improved processes. They will coordinate special projects through task delegation and effective communication with all organizational disciplines and management levels. They will interact with internal business process areas, multiple BD plants, division, and worldwide operations with emphasis on quality improvement programs. They will also interact professionally with BDM, PS customers on project management. Regular, punctual attendance is an essential job function. Ability to speak, read and write English. Ensures compliance with BD quality systems, policies, procedures and practices and all local, state, federal and BD safety regulations, policies and procedures.
Participate on the worldwide extended QE&TT team for Pharmaceutical Systems and interface with worldwide functions as main contact for site Quality engineering.
Manage the team of Project Quality Engineers and Site Validation Leader.
Ensure compliance of the production documentation and practices to specifications and control plans.
Provides technical input for projects using the application of FMEA's, risk mitigation, plant validations, DOE's, and other experiments and investigations as appropriate.
Oversee the validation activities.
Contributes to machine and process capability studies.
Maintains familiarity with the manufacturing processes and products to evaluate the cause and effect of defects.
Oversees/leads projects using the application of continuous improvement tools.
Manages the activities associated with the quality engineering function.
Appropriate escalation of quality issues.
Directs attention to the career path and development of direct reports while working to develop technical expertise and managerial competency.
Reviews departmental budget and controls discretionary cost.
Other duties as assigned.
Education & Experience:
Bachelor's degree in Engineering, Quality Assurance, Mathematics/Statistics or Science Related field required (Master's degree preferred)
5-7 years manufacturing experience working with Validations, FMEA, Risk Management, IQ, OQ, PQ and DOE's is desirable.
Six Sigma trained, highly desirable
Advanced skills required in:
Quality Tools (MSA, Cabability, FMEA, Validations, Root Cause)
Proficient skills required in:
Quality Systems Knowledge
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