BD (Becton, Dickinson and Company) Quality Engineer II in Sumter, South Carolina
Job Description Summary
Performs statistical analysis of new and existing processes, identifying root cause of product defects and process waste and recommending to management appropriate corrective action(s). Evaluates all changes, modifications and additions to product lines and determines the effect on product quality. Coordinates the total Quality Awareness Program within his/her
Through the use of accepted statistical engineering principles and experimentation design, initiates capability studies of processes to identify causes of chronic levels of defects and remedy those areas associated with a high cost of quality.
Provides functional support to the Engineering Department for the writing of protocols, data gathering and data analysis associated with the Plant Validation Program – including prospective, retrospective and revalidation efforts. Conduct process capability studies and/or process optimization studies prior to validations.
Acquires data from critical processes allowing for trend analysis and recommends action to be taken to maintain/obtain statistical process control.
To assure coordination of the overall quality effort within the plant in the following areas:
Provides plant self- audit information on the product and process to assure compliance with all government regulations (QSR, FDA and Contractual).
Periodically reviews Quality specifications to assure accuracy and adequacy.
Formulates and implements policies and procedure relating to product quality or process control as appropriate.
Provide test and statistical support to customer complaint issues that arise and make recommendations on actions to be taken.
Conducts vendor (equipment and/or raw material) quality evaluations at vendor sites as required.
May also support the Validation initiative through the planning, review, and evaluation of validations as required
Bachelor of Science degree in Engineering or related science
Minimum of 3 years of experience in manufacturing
Experience with SAP preferred
Experience in Lean/Six Sigma preferred
ASQ CQA, CQE, CMQ/OE preferred
Computer proficiency in Microsoft Office (Word, Excel, Power Point, Outlook)
Must have validation experience in manufacturing
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.
Primary Work LocationUSA SC - Sumter
Work Shift1st Shift 8am-530pm (United States of America)
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