BD (Becton, Dickinson and Company) Supplier Quality Engineer in Zelienople, Pennsylvania
This position is responsible for the development, documentation, and management of Supplier Quality Control processes as required supporting facility/division/corporate quality objectives. This position will lead both Supplier Quality Engineering in the areas of DfX, supplier development, and component qualifications. This individual will be also be responsible for supplier audits, owning and maintaining the Approved Supplier List (ASL) and for monitoring and reporting on supplier performance issues. The Supplier Quality Engineer will manage SCARS and support Operations and the Material Review Board as required.
Actively engage with product development teams and suppliers to drive DfX, part qualification requirements and control planning activity
Work with design and supplier to develop critical to quality criteria for purchased component and/or subassemblies
Proactively work with suppliers to understand purchasing and design specifications to drive first time right receipt of component and subassemblies for the manufacturing life of the product
Perform supplier development activity as required
Understand the critical to quality requirements of existing purchased components or subassemblies to drive root cause analysis or supplier corrective actions
Lead Supplier Quality Auditing processes for the BES-Dymax Quality Assurance Team
Create and Maintain supplier audit schedules, agenda’s, and reports
Drive root cause and permanent corrective action and all supplier non-conformances
Sustain the BES-Dymax (ASL) approved supplier list
Consolidate ASL to improve quality, remove redundancy, and cost reduction
Maintain a constant up to date ASL approvals, limited approvals, and disapprovals
Lead and ensure the completion of all new supplier/part approval requirements:
Qualification Audits / Assessments
Design Qualification protocols and reports
Part Qualifications: i.e. (FAI) first article inspections, Capability studies, Process Control Plans, Gage R & R, Process validation (IQ, OQ, PQ), and process flow charts
Provide supplier related quality assurance sustaining engineering support to established product lines
Assist Material Review Board in the investigation of material defects and failures
Participate on New Product Development and Project Transfer teams to ensure the completion of all approval and transfer of suppliers into the BES-Dymax supplier management system
Assist Procurement, Materials and Engineering in the selection of new suppliers
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 permanent corrective action
Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc) 3-5 years of experience in the manufacture of Electro-Mechanical devices 1-3 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
Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc)
3-5 years of experience in the manufacture of Electro-Mechanical devices
1-3 years experience in an FDA regulated Medical Device Manufacturing environment preferred.
Career Level: experienced
Division Name: Bard Electronic Systems
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 141 Zehner School Road
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.