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Software Validation Engineer
4 months ago
· Effectively assess regulatory and validation requirements for computer systems within organization
· Identify and develop all required computer system validation deliverables including but not limited to validation plan, user and functional requirements, regulatory requirements, test strategy, IQ/OQ, deployment plan, traceability matrix, validation summary and others
· Ensures compliance to all relevant Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
· Experience in ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance
· Provide verification/validation activities project estimates per the department operating procedures.
· Develop, own and execute to well defined timeline and project plan
Company DescriptionAbout Kyyba:Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Kyyba is an Equal Opportunity Employer
Benefits:
Major Medical Coverage, including dental and vision
401k
Term life
Short-term disability
Long-term disability
Pre-paid legal plan
Identity theft plan
Medical and dependent FSA
HSA
Paid time off
Paid holidays
Opportunity for advancement
SELECT AWARDS
•\tAn INC 5000 company for 10 years
•\tCorp Michigan Economic Bright Spots
•\tCrain’s Detroit Business Top Staffing Service Companies in Detroit
•\tTechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
•\tBest of MichBusiness winner in HR Wizards & Partnerships
•\tMetro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
•\t101 Best & Brightest Companies to Work for in Michigan
Monday - Friday: 8:30am to 5pm.Company DescriptionAbout Kyyba:\r
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.\r
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development. \r
\r
Kyyba is an Equal Opportunity Employer\r
\r
Benefits:\r
Major Medical Coverage, including dental and vision\r
401k \r
Term life\r
Short-term disability\r
Long-term disability\r
Pre-paid legal plan\r
Identity theft plan\r
Medical and dependent FSA\r
HSA\r
Paid time off\r
Paid holidays\r
Opportunity for advancement\r
\r
SELECT AWARDS\r
•\tAn INC 5000 company for 10 years\r
•\tCorp Michigan Economic Bright Spots \r
•\tCrain’s Detroit Business Top Staffing Service Companies in Detroit\r
•\tTechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions\r
•\tBest of MichBusiness winner in HR Wizards & Partnerships\r
•\tMetro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest\r
•\t101 Best & Brightest Companies to Work for in Michigan\r
\r
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Monday - Friday: 8:30am to 5pm.
