6 days old

Software Quality Assurance Eng

San Diego, CA 92130
  • Job Code
  • Payrate
    $47 To $49
job summary:

The Software Quality Engineer position provides support for the validation and continued maintenance of Non-Product Software Systems that automate business processes required by medical device regulations and/or standards.

location: San Diego, California
job type: Contract
salary: $47 - 49 per hour
work hours: 8 to 5
education: Bachelors

- Manage, lead and educate business partners across multiple Business Groups (BGs) in the generation, execution and completion of computerized software system validations.

- Provides guidance/feedback to with respect to applicable FDA regulatory requirements, Industry Standards and Philips policies and procedures.

- Authors, reviews and/or approves SW validation deliverables for non-product Software including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports.


- Minimum 5 - 10 years of experience in software validation of R&D, Manufacturing and large scale computer systems (e.g. HP Quality Center, SAP, Trackwise, Enovia, Windchill, DOORS, etc.)

- Experience working in disciplined regulated industry in the application of automated technology and applied knowledge particularly; 21 CFR part 820, Part 11, ISO 13485, AAMI TIR 36, FDA Guidance, General Principles of Software Validation and GAMP 5.

- Experience in leading and educating teams on the appropriate validation documentation created as objective evidence for software validations per company procedures, standards and regulations (e.g. 21 CFR part 820, Part 11, ISO 13485, AAMI TIR 36, FDA Guidance, General Principles of Software Validation and GAMP 5).

skills: - Bachelor of Science degree (BS) in Computer Science, Electrical Engineering, Systems Engineering and or IT related fields; but any advanced degrees are preferable in Quality, Regulatory and Software Engineering.

- Effective judgment and decision making skills, typically made under stressful situations.

- Competency in project management and the execution of multiple projects.

- Demonstrated capability in critical thinking and leadership with strong abilities in relationship management.

- Ability and willingness to travel 10% domestic and international.

- Fluent in English, Spanish is a plus but not required.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.


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Software Quality Assurance Eng

Randstad Technologies
San Diego, CA 92130

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Randstad Technologies
San Diego, CA

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