|09-12-2016, 08:29 AM||#1|
Location: San Francisco Bay Area
Join Date: Oct 2008
Quality Engineer - Reagents
Pacific Biosciences is looking for a Quality Engineer to support the reagent products. He/she is responsible for developing quality processes and methodologies: working closely with the Manufacturing and R&D staff to ensure quality is an integral part of their design control process. The Quality Engineer is responsible for driving continual product and process improvement and to provide compliance guidance.
• Support the Reagent development on product development and product transfer to manufacturing
• Support the product development team on product Verification & Validation
• Support the Reagent manufacturing team on good manufacturing practices
• Work with R&D on all elements of Design Control. Participate in design reviews to assure product subsystem quality, reliability, etc.
• Audit manufacturing and R&D against released design control processes and procedures
• Establish and maintain quality plans, to assure products will meet expectations of our target customers.
• Establish and maintain quality performance metrics
• Assist in the identification and resolution of quality issues. Manage and facilitate the root cause & corrective actions system through tracking and validation of issues.
• 4 year Technical Degree, a BS degree in Molecular Biology (or a related field) is preferred
• 7-10 years of quality systems experience
• Strong understanding of reagent development for an IVD product
• Experience with DNA sequencing technologies
• Expert knowledge of ISO 13485 and 21 CFR Part 820 (Design Control)
• Experience with ISO 14971, FMEA, and IEC 62366
• Experience with 510k filing
• Applicants must possess strong written and verbal communication skills
• Experience in a Life Science/Biotech company that has both an instrument and consumable products a plus
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.