Job summary
Job post source
This job is directly from Katalyst CRO
Job overview
The System Validation Engineer at Katalyst CRO ensures software quality assurance for non-product software in medical device development, maintaining regulatory compliance and supporting audits.
Responsibilities and impact
The role involves developing and maintaining software quality assurance processes, ensuring adherence to FDA and ISO standards, supporting regulatory audits, validating computerized systems, creating and reviewing validation deliverables, conducting periodic reviews, system retirement, and collaborating with software and IT teams to improve quality and compliance.
Experience and skills
Candidates need a bachelor's degree in engineering or a related field, 4-5 years of experience in software quality assurance or validation in the medical device industry, strong knowledge of FDA, ISO, and IEC standards, experience with non-product software validation, and familiarity with tools like JIRA and JAMA is a plus.
Unique job features
This position focuses specifically on non-product software validation within the regulated medical device industry, emphasizing compliance with multiple regulatory standards and continuous process improvement.
Company overview
Katalyst CRO is a contract research organization specializing in providing comprehensive clinical trial management and support services to pharmaceutical, biotechnology, and medical device companies. They generate revenue by offering tailored solutions in clinical operations, regulatory affairs, data management, and biostatistics to accelerate drug and device development processes. Founded with a focus on innovation and efficiency, Katalyst CRO emphasizes collaboration and cutting-edge technology to deliver high-quality results. Their expertise spans multiple therapeutic areas, making them a trusted partner in advancing healthcare solutions globally.
How to land this job
Position your resume to highlight your expertise in software quality assurance and system validation, especially for non-product software in medical device development, emphasizing your familiarity with FDA, ISO 13485, and IEC 62304 standards.
Focus on showcasing your experience with creating and reviewing validation deliverables such as requirement specifications, validation plans, qualification protocols, test reports, and traceability matrices, as these are core responsibilities for the role.
Apply through multiple channels including Katalyst CRO's corporate career site and LinkedIn to maximize your chances of being noticed by recruiters and hiring managers.
Connect with professionals in Katalyst CRO's quality assurance or regulatory affairs divisions on LinkedIn, using ice breakers like commenting on recent regulatory changes affecting medical software or asking about best practices in non-product software validation within the company.
Optimize your resume for ATS by incorporating keywords from the job description such as 'Computer System Validation,' '21 CFR Part 11,' 'GxP,' 'FDA,' 'ISO 13485,' 'IEC 62304,' and 'validation deliverables' to ensure it passes automated screening tools.
Consider using Jennie Johnson's Power Apply feature to automate tailoring your resume, identifying multiple application portals, and finding relevant LinkedIn contacts, allowing you to focus your energy on preparing for interviews and advancing your career.
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