Supplier Quality Engineer
Develop and implement appropriate supplier quality system elements to ensure continuous improvement by outside suppliers as well as their compliance with all applicable regulations and standards. Analyze situations and data to recommend solutions, and communicate and implement quality objectives both internally and externally.
Specific Duties and Responsibilities:
- Participate in the materials selection, development and qualification activities for new and existing suppliers
- Participate as a technical expert in the sourcing and selection of suppliers
- Coordinate and participate in the external supplier audit program
- Perform supplier qualification studies
- Perform gauge repeatability and reproducibility studies
- Align testing and inspection methodology at Penumbra with supplier inspection/testing programs
- Interface with suppliers on the use of Quality Engineering methodologies, tools, quality and regulatory requirements, etc. and assist in solving day-to-day quality issues
- Coordinate NCRs and Supplier Corrective Action Requests (SCARs)
- Develop and support an effective incoming material quality and dock-to-stock program
- Support material characterization studies
- Recommend revision of specifications, procedures and work instructions for material or process improvement
- Interface with other internal departments, customers and suppliers on quality-related issues
Position Qualifications:
Education: B.S. in Engineering
Experience: At least 3-5 years of quality engineering, preferably in a medical device, pharmaceutical or comparable regulated environment with working knowledge of QSR, ISO and other applicable regulations and laws; expertise in statistical methodologies and analysis. Training and experience in performing internal and external audits; certification preferred.
If you are interested in employment opportunities at Penumbra, please Mail, Fax or E-mail your resume including salary requirements to:
Penumbra Inc.
1351 Harbor Bay Pkwy
Alameda, California 94502
Telephone: (510) 748-3200
Fax: (510) 814-8308
Email: hr@penumbrainc.com