Senior Quality Engineer - Software

Menlo Park, CA, United States
Jul 08, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Pacific Biosciences is looking for a Quality Engineer to support the Software Development Teams. The successful candidate 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.

  • Support the Software teams every step of the Software Development Life Cycle.
  • Participate in product development processes such as Core Teams, Bug scrubs, Sprint Planning, Verification and Technical reviews.
  • Review the Software related documentation (architecture, functional specification, plans, etc.) for compliance and completeness.
  • Coach & train the Software development teams on the applicable regulations and standards.
  • Provide expertise in dFMEA creation and maintenance, requirements analysis, traceability from requirements to verification, and testability.
  • Look at regulatory control in an increasingly fast-paced software environment including continuous deployment and delivery.
  • Assist in the identification and resolution of quality issues and complaints. Facilitate and manage the root cause & corrective actions implementation.
  • Support field actions related to the Software.
  • Audit SW development teams against released design control processes.
  • Support Computer System Validation process.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Position Requirements:
  • 4-year Technical Degree, a BS degree in Engineering or Computer Science is preferred
  • 6-7 years in a Quality role in an ISO 9001:2015 or ISO 13485 environment or
  • 6-7 years as a software tester in an IVD environment or
  • 6-7 years in a software program management role in an IVD environment
  • Working knowledge of Agile Software Development Process
  • Experience in a regulated industry, preferably with medical devices. Experience with DNA sequencing technologies is a plus.
  • Expert knowledge of Computer System Validation process.
  • Expert knowledge of IEC 62304, ISO 9001, ISO 13485 and 21 CFR part 820
  • Expert knowledge of ISO 14971 and FMEAs
  • Working knowledge of 21 CFR part 11
  • 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.