Medical Device Validation Engineer
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Job Description
Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc.,
Collaborate with the cross functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met.
Review of CAPAs, Change Controls and Defects for GxP applications.
Working with Global teams and provide audit support
Working with a range of applications/tools including ALM, TrackWise, JIRA, Confluence, and other integration tools.
Education min. / Experience min.- -
Bachelor s with 8+ years of exp. or Master s with 5+ years of exp. (Required: Resumes must include the candidate s Bachelor s or Master s graduation year.)
Top 5 skills/requirements
Prior experience in regulated industry - GxP systems.
Good knowledge of FDA regulations; 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485 and ISO 27001.
Quality Management Tools and Test Management Tools TrackWise/ComplainceWire/Veeva, ALM, JIRA etc.,
Knowledge about Data Integrity and prior audit support experience (Internal/External).
Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS) and Custom applications
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.