Katalyst CRO
Validation Quality Engineer
– Katalyst CRO
Our team is looking for an experienced Validation Quality Engineer to support the development and release of medical device software. The successful candidate will provide technical guidance and quality oversight throughout the lifecycle of product software, ensuring compliance with regulatory and company standards.
Roles and Responsibilities
Lead meetings to prioritize, review, and approve action plans for addressing issues captured in problem resolution systems during development.
Lead risk evaluation and management activities related to product software development, including FMEA, risk analysis, and mitigation of software issues.
Participate in technical and management reviews to ensure design plans, product design, and deliverables meet requirements, representing the quality engineering function for the review and approval of designated design controls.
Provide quality oversight for non‑product software validation as required, preparing and supporting protocols, reports, and other documentation.
Support product cybersecurity assessments in collaboration with cross‑functional teams.
Comply with US FDA regulations, other country regulatory requirements, company policies, and procedures.
Maintain strong, collaborative partnerships with cross‑functional team members, especially software suppliers.
Work as an individual contributor and provide guidance to other QE team members.
Education & Experience
Background in medical device R&D product software.
Experience in the medical/pharma domain.
Minimum 2–3 years of quality experience in product software validation.
Expertise in software quality engineering or validation engineering.
Knowledge of software quality, design controls, NSTP validation, risk assessment & mitigation, IEC 62034, ISO 14971.
Seniority level : Associate
Employment type : Contract
Job function : Quality Assurance
Industry : Pharmaceutical Manufacturing
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– Katalyst CRO
Our team is looking for an experienced Validation Quality Engineer to support the development and release of medical device software. The successful candidate will provide technical guidance and quality oversight throughout the lifecycle of product software, ensuring compliance with regulatory and company standards.
Roles and Responsibilities
Lead meetings to prioritize, review, and approve action plans for addressing issues captured in problem resolution systems during development.
Lead risk evaluation and management activities related to product software development, including FMEA, risk analysis, and mitigation of software issues.
Participate in technical and management reviews to ensure design plans, product design, and deliverables meet requirements, representing the quality engineering function for the review and approval of designated design controls.
Provide quality oversight for non‑product software validation as required, preparing and supporting protocols, reports, and other documentation.
Support product cybersecurity assessments in collaboration with cross‑functional teams.
Comply with US FDA regulations, other country regulatory requirements, company policies, and procedures.
Maintain strong, collaborative partnerships with cross‑functional team members, especially software suppliers.
Work as an individual contributor and provide guidance to other QE team members.
Education & Experience
Background in medical device R&D product software.
Experience in the medical/pharma domain.
Minimum 2–3 years of quality experience in product software validation.
Expertise in software quality engineering or validation engineering.
Knowledge of software quality, design controls, NSTP validation, risk assessment & mitigation, IEC 62034, ISO 14971.
Seniority level : Associate
Employment type : Contract
Job function : Quality Assurance
Industry : Pharmaceutical Manufacturing
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