BD (Becton, Dickinson and Company) Senior Supplier Quality Engineer in Zelienople, Pennsylvania
Category: Quality Engineering
Job ID: 2018-11642
Career Level: experienced
Division: Bard Electronics System
Location: Zelienople,Pennsylvania,United States
This position is responsible for the development, documentation, and management of Supplier Quality Assurance and Control processes as required to support facility/division/corporate quality objectives. This position will act as the Supplier quality consultant to transfer project teams, and will lead projects to resolve supplier quality issues. This position is also responsible to manage the BES-Dymax Material Review Board, to participate in qualification efforts for new suppliers, to monitor and report on supplier performance of existing suppliers, and to perform on-site audits of supplier quality systems.
Essential job Functions:
Lead the BES-Dymax Material Review board and assist in the investigation of component defects and failures,
Participate on New Product Development and Project Transfer teams to facilitate the approval and transfer of suppliers into the BES-Dymax supplier management system.
Assist Materials and Engineering in the selection of new suppliers, and conduct qualifications and/or surveillance audits of new or established suppliers to BES.
Track supplier performance and prepare and issue monthly reports of supplier and material quality performance, issues, and actions
Issue Supplier Corrective Action Requests as appropriate in response to detected supplier quality trends, and follow-up with suppliers on root cause investigation and closed loop corrective action.
Plan and perform component, supplier, and process qualifications including First Article Inspections, and the preparation of written test protocols and reports.
Provide supplier related quality assurance sustaining engineering support to established product lines
Work with suppliers to identify and support process and product improvements in support of quality and cost improvement projects.
Develop quality inspection processes, tests, techniques, tools, and fixtures, and train the production, service, and quality control staffs as needed to perform their respective duties.
Develop written quality plans, and quality inspection and test procedures
Create and review Risk Assessments and Rework Plans for component and product related issues including use-as-is and rework dispositions.
Design and conduct Quality Engineering studies to determine causes of quality non-conformances, initiate changes in process, tooling, product design, etc. to correct them.
Support the goals of the Quality Organization, Continuous Improvement efforts and Cost Improvement Projects.
Other duties as required.
Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc)
5-7 years of experience in the manufacture of Electro-Mechanical devices
3-5 years experience in an FDA regulated Medical Device Manufacturing environment preferred
Team leader / player comfortable communicating with broad audiences
A solid understanding of the FDA QSR and/or ISO 9000/ISO 13485 Quality System Requirements specifically in design controls and design transfer and supplier controls
Excellent oral and written communication skills to prepare written technical plans and reports in support of engineering changes, product or process validations, and component qualifications
Strong project planning skills and a strong focus on meeting customer needs
ASQ Certified Quality Engineer, a plus
ASQ Certified Quality Auditor, a plus
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