3 Senior Software QA Engineer Jobs in Maple, MN
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Senior Software QA Engineer
$82k-100k (estimate)
Full Time | Business Services
3 Weeks Ago
intellectt is Hiring a Senior Software QA Engineer Near Maple, MN
Job Title - Senior Software QA Engineer
On site Maple Grove, MN
Long term contract
What You’ll Do
On site Maple Grove, MN
Long term contract
- Long term contract -- majority of contractors have been on-site 2 years
- Extensive experience in a Software Quality Assurance (SQA), Computer System Validation (CSV) or similar role, supporting an Enterprise Heath care, Medical Device, Life science, etc., type environment
- Extensive experience supporting a portfolio and variety of Validated Systems (i.e. ServiceNow, Document Mgmt., Learning Mgmt., ERP, MES, etc.)
- Expert/SME knowledge of CFR Part 11 and the relevant Software Lifecycle -- FDA QSR, ISO guidelines
- Strong experience with ALM, Mfiles
- Strong communication experience -- requirement gathering, stakeholder mgmt.
What You’ll Do
- Completes SQA tasks in accordance with current Quality System Requirements.
- Works independently with objectives given by SWQA Manager or QA Director.
- Can plan and coordinate own work according to higher-level project schedules.
- Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
- Ensure documentation accuracy, clarity, consistency, completeness, and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports.
- Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.
- Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC Abbott and Lingo software/firmware products.
- Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems.
- May Develop and maintain Validation Master Plan(s).
- May have responsibilities to monitor and direct the work of contractors/temporaries.
- Ensure that Abbott and Lingo computerized systems used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.
- Ensure that deliverables and activities are in compliance with current Software/SWQA processes in the development of Lingo software/firmware products.
- Abbott experience
- CFR 820 and relevant CFR regulations
- Long term contract -- majority of contractors have been on-site 2 years
- Growing life sciences industry
- highly respected Fortune 100 organization
- fast paced, complex, high expectations -- must be very detail oriented
- new projects -- growing application presence in Corp IT for Nutrition and Med Device BUs
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$82k-100k (estimate)
POST DATE
06/02/2024
EXPIRATION DATE
08/06/2024
WEBSITE
intellectt.com
HEADQUARTERS
ISELIN, NJ
SIZE
200 - 500
FOUNDED
2018
CEO
KIRAN MADALA
REVENUE
$5M - $10M
INDUSTRY
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
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