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Sr. Quality Engineer

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POST DATE 12/5/2019
END DATE 12/28/2019

Varian Medical Systems, Inc. Palo Alto, CA

Location
Palo Alto, CA
AJE Ref #
585688156
Job Classification
Full Time
Job Type
Regular
Company Ref #
16589BR
Experience
Mid-Career (2 - 15 years)
Education
Bachelors Degree

JOB DESCRIPTION

WE'RE DRIVING TOWARD THE ULTIMATE VICTORY: A WORLD WITHOUT THE FEAR OF CANCER.Be a member of the Design Quality Engineering team. As part of sure you ensure that FDA, 1S013485 and other regulatory standards are met.In depth understanding of the Engineering Design Process, particularly for software controlled medical products is required. Foster attention to quality and compliance.Partner with Software Engineering, Hardware Engineering and Manufacturing teams to assess risk, to develop software design plans and documentation, to review design, and to demonstrate software and system capability and maturityAssist in the creation of verification and validation plans, protocol and reports.Lead the implementation of quality systems and work closely with Design, Quality and Manufacturing Engineering personnel during the development and introduction of new products and technologies.Ideal for someone with design engineering development and manufacturing or related technical background, transitioning into FDA/ISO complianceWork with design engineering and manufacturing applications groups to develop strategies to improve the effectiveness of product/mechanical and manufacturing testing at all stages.Reviewing product requirements, as well as engineering requirements and design for clarity, testability and completeness. Emphasis is quality by design, not only by testing.Act as independent reviewer on project teams for various engineering reviews such as product requirements, system requirements, system design, architectural design, code reviews/walkthroughs, TRR (Test Readiness Reviews), V&V procedures and reports, risk management, transfer to manufacturing, DMRI, DHR etc.Attend phase gate reviews and challenge engineering with critical questions.Review/audit of Design History Files (DHFs) and Technical Files.Review and closely follow-up of design control process related audit non-conformances, CAPAs (Corrective and Preventive Actions), DRs (defect reports),customer complaints/field problems, to establish a closed-loop system.Draft processes, procedures, instructions and templates related to design controls with cross functional teams Minimum Required Skills and Knowledge: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with SAP or equivalent ERP product and productivity software desired. Typical Education and Experience: Bachelors degree (or equivalent experience) and 8 years of related experience or Masters Degree with 6 years of related experience.

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