Katalyst CRO · 1 month ago
Validation quality Engineer
San Diego, CA
Contract
Onsite
Mid, Senior Level
2+ years expKatalyst Healthcares & Life Sciences is seeking a Validation Quality Engineer who will provide technical and quality system guidance for establishing software as a medical device requirements. The role involves overseeing verification and validation activities for new products, as well as leading risk evaluation and management activities related to product software development.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development
Leads risk evaluation and associated management activities related to product software development including Risk assessments (e.g. FMEA), product risk analysis, and mitigation of software issues
Participates in technical and management reviews to ensure design plans, product design and deliverables related to product software are met. Represent the quality engineering function for the review and approval of designated design controls
May provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required
May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures
Maintains a strong, collaborative partnership with cross functional team members especially with software supplier
Works as an individual contributor and may provide guidance of other QE team members
Qualification
Required
Provides technical and quality system guidance related to establishing product software as a medical device requirements
Provide quality oversight for product software as a medical device verification and validation activities for new products in accordance with design planning procedures
Reviewing and approving software test case protocols and reports
Review of software development plans
Review of other system and software documentation
Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development
Leads risk evaluation and associated management activities related to product software development including Risk assessments (e.g. FMEA), product risk analysis, and mitigation of software issues
Participates in technical and management reviews to ensure design plans, product design and deliverables related to product software are met
Represent the quality engineering function for the review and approval of designated design controls
May provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required
May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures
Maintains a strong, collaborative partnership with cross functional team members especially with software supplier
Works as an individual contributor and may provide guidance of other QE team members
Medical device – R&D product software
Resource shall have a background in the medical/pharma domain
Resource shall have product software validation experience and a minimum of 2 to 3 years of experience in Quality
Resource shall have experience as a Software Quality Engineer or Validation Engineer and Quality Engineer
Product software Quality, Design Controls, NPSW Validation, Risk Assessment & Mitigation, IEC 62034, ISO 14971
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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