BD (Becton, Dickinson and Company) Quality Engineering Manager - Medical Device Manufacturing in Holdrege, Nebraska
Job Description SummaryThe Quality Engineer Manager will lead all Quality Engineering activities and incoming quality issues. Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational competence within area of responsibility. Ensure the systems and products comply with applicable government regulations. Comply with all BD quality policies, procedures and practices through consistent application of sound quality engineering/assurance principles.
This position offers full relocation benefits
Evaluate, design, implement and improve a production and process control strategy to achieve quality management and plant objectives.
Participate on material review board. Provide quality engineering support to product/process validation effort.
Review and approve changes to the device master record.
Review and approve qualifications and validation protocols and results.
Develop and approve strategic quality planning.
Provide appropriate oversight and direction to quality engineering projects. Support continuous improvement processes, ie: lean manufacturing, root cause determination, control plans and six sigma and statistical problem solving.
Oversee the vendor qualification and certification programs in collaboration with supply management and supply quality engineer.
Comply with all BD quality policies, procedures and practices through consistent application of sound quality assurance principles.
Comply with all local, state, federal and BD safety regulations, policies and procedures.
Provide effective quality engineering leadership in teamwork development, effective communication and quick responses to customer needs.
Build organization capability for quality engineering in the selection and mentoring of professionals.
Build a strong interactive, working and strategic relationship with BD Holdrege manufacturing, corporate quality management and other staff.
Function as primary respondent during FDA, ISO and other 3rd party audits and follow up on any action plans.
Responsible for managing 4-7 associates.
Bachelor’s degree in Engineering, Quality Assurance, Mathematics/Statistics or Science Related field required
5-7 years manufacturing experience working with Validations , PFMEA, Risk Management and DOE's is desirable.
Minimum 3-5 years management experience in a regulated manufacturing environment.
ADDITIONAL AND PREFERRED SKILLS AND QUALIFICATIONS
Six Sigma trained, highly desirable
Quality Tools (MSA, Capability, PFMEA, Validations)
Quality Systems Knowledge
Root Cause Methodology
Primary Work LocationUSA NE - Holdrege
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