Senior Software Quality Engineer

Organization
Pacific Biosciences
Job Location
1380 Willow Road
Menlo Park, CA 94025
Job Description

Pacific Biosciences is looking for a Quality Engineer to support the Software Development Teams.  He/she is responsible for developing quality processes and methodologies: working closely with the 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. 

 Responsibilities:         
•    Support the Software teams every step of the Software Development Life Cycle
•    Coach & train the Software development teams on the applicable regulations
•    Participate to the Software requirement reviews.
•    Review the Software related documentation (architecture, functional specification, validation plans, etc) for compliance and completeness
•    Participate in technical design reviews and change control board. 
•    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. 
•    Audit SW development teams against released design control processes

Requirements

•    4 year Technical Degree, a BS degree in Engineering or Computer Science is preferred
•    7-10 years of quality systems experience
•    Working knowledge of various Software Development Lifecycle
•    Experience in regulated industry, preferably with medical devices.  Experience with DNA sequencing technologies is a plus.
•    Expert knowledge of IEC 62304
•    Expert knowledge of ISO 13485 and 21 CFR Part 820
•    Working knowledge of ISO 14971, and IEC 62366
•    Applicants must possess strong written and verbal communication skills 

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.

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