BD (Becton, Dickinson and Company) Senior Supplier Quality Engineer in Zelienople, Pennsylvania

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.

  • 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

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.

ID: 2018-11642

Career Level: experienced

Division Name: Bard Electronics System

Relocation: No

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.