BD (Becton, Dickinson and Company) Senior Quality Engineer in San Jose, California
Job Description SummaryThe Sr. Quality Engineer is accountable for supporting product sustaining activities through the application of Quality engineering skills for medical devices.
For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established BD standards of quality. Successful performance requires close work with quality management, operations, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices. The incumbent will be capable of self- direction and project management to ensure successful outcomes.
Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
Guides the successful completion of major programs and may function in a project leadership role.
Support product sustaining activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development.teams and identifying Quality needs, product improvements and customer requirements.
Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working withManufacturing, Service, Engineering, Regulatory and Biostatics.
Initiate Corrective and Preventative Action plans and perform efficacy follow up.
Work collaboratively and cross functionally to improve product performance.
Utilize trouble shooting and problem solving skills to identify and eliminate issues that negatively impact product performance
A minimum of 5 years of experience working within a quality function.
A minimum of 5 years of experience working in a FDA or ISO regulated environment.
A minimum of a bachelor’s degree is required.
BS Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related scienceCertified Quality Engineering (CQE) preferred.
Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools.
Excellent people interaction, team building, and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis expected.
Primary Work LocationUSA CA - San Jose
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