Principal Systems/Software Quality Engineer - Design QA (RE-12454447) Dublin, California

Salary: USD50 - USD70 per hour + Negotiable

Software Quality Assurance (Design Control)

Title: Principal Scientist, Systems/Software

Location: Pleasanton,CA

Duration: 1 year contract before conversion to FTE (regular employee)

Function:

  • Provide design control and software/systems development guidance to new and/or revised product development teams and life cycle teams and be the single point representative for Design Quality Assurance activities for Life Cycle and Product Teams dealing with system and software products.
  • Review and approve documentation consistent with design control regulations and guidance’s dealing with systems/software development, verification and validation practices and SOPs (customer requirements, product requirements, design and development plans and reports, verification and validation plans and reports, design transfer documents, labeling, risk management plans and reports, project plans and milestone documentation)
  • Author and/or review and approve Quality Plan and Reports.
  • Assist in the development of high level and departmental SOPs governing or associated with design control activities and compliance.

Education:

  • Bachelor’s or QE degree in Computer Science, Engineering or a related scientific discipline -or- an equivalent combination of education and work-related experience in the area of software/systems development, verification and validation.

Experience:

  • Minimum of 5-6 years of experience, preferably 8-10 years of experience
  • Development and/or QA experience of software, instrument systems under design controls and intermediate/advanced knowledge of in vitro diagnostic reagents, instruments and software products including nucleic acid based products.
  • Strong working knowledge of QSR/cGMP, Design Controls, Systems/Software Development, Verification and Validation Principles and Practices, ISO, EU IVD Directive.
  • Strong track record of successful participation on cross-functional project teams.

Additional Notes:

  • Looking for a senior or manager level candidate, sole contributor very hands on, document heavy, process heavy, reviewing test protocols, no coding, any experience with a diagnostics platform will be hugely beneficial, testing, verification, validation, FDA experience. This position will act on several different project based teams at once and provide QA oversight in compliance with SOPs

Interview slots are already booked in with the manager for Wednesday, Thursday and Friday this week. Apply immediately by submitting your resume and you will be contacted shortly.