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Talentfuse
Software QA Engineer
SAN DIEGO, CA
Salary: $0 - 0 / Annually
Job Type: Full Time
Category: Computer-IS
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Software Q A Engineer
Department: Quality Assurance
Category: Quality Assurance
Type: Temp., Full-time
Description: This position will be responsible for competing
specific software validation tasks as assigned by the software
validation manager or designated validation lead. This includes
validation do***entation and deliverables required to meet
company quality standards and regulatory compliance. The engineer
will write validation do***entation and perform validation tests
on validation projects. These projects include Biosite custom
developed software, externally custom developed software,
configurable off-the-shelf software, and custom developed
spreadsheet applications. The engineer will coordinate with the
project team, validation lead and customers to create high
quality do***entation and meet validation needs. This includes
developing basic test protocols, developing basic test plans,
executing validation tests and creating summary re****ts. The
validation engineer will contribute to complex validation project
plans, estimates, reviews and other activities as required.
Tasks and Responsibilities:
Implement practices to sup****t quality standards, applicable
regulatory compliance, company guidelines / policy using sound
software validation practices
Follow established policies, processes and SOPs to sup****t
software validation work
Analyze and recommend improvements to software validation
processes, procedures and practices
Write re****ts and follow-up on recommendations to improve systems
and procedures
Ensure accuracy and completeness of software validation records
Recommend software validation implementation strategies and
tactics to the software validation manager as required
Ability to work independently on routine work and complex
projects or assignments
Collaborate with project teams to plan, analyze, organize and
execute assigned projects and duties as required
Understand and uses the software under testing
Possess a basic understanding of the software tested and has an
understanding of the system development lifecycle
Maintain knowledgeable of federal and other regulations, e.g.
QSRs, ISO, ISO 13485, CMDR, 21CFR11
Demonstrate professional behavior with internal / external
business associates
Conduct business relation****ps and interactions in manner that
reflects positively on the company and is consistent with policy
and practice
Ability to prioritize in a fast-pace environment
Other responsibilities as assigned
Requirements: Preferred educational background:
Typically requires a Bachelors degree or equivalent in Computer
Science or Information Systems or related field.
Preferred experience and background:
Typically 0-2 years experience in information systems, computer
science - preferably in a regulated industry
Typically 2 years experience in performing software validation
activities on system implementation projects analysis, testing,
planning, re****ting and do***enting
Demonstrated analysis, communication, collaboration, problem
solving and communication skills
Location San Diego , CA
Minimum Experience (yrs): 0-2
Required Education: Bachelors
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(See Job Descripton)
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Contact Information
Talentfuse
Reference Num: 2819-21-MH303 (include when applying)
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