Validation Engineer/CSV Engineer

Katalyst Healthcares & Life Sciences; Walnut Creek (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A healthcare services company in Walnut Creek, California is seeking candidates for a role in software quality assurance within medical device development. The successful applicant will develop and maintain quality assurance processes, ensuring compliance with FDA and ISO standards. This position requires a bachelor's degree and 4-5 years of relevant experience. The ideal candidate will have strong knowledge of software validation and regulatory guidelines, as well as familiarity with tools like JIRA and JAMA. Competitive compensation is offered.

Qualifications

• 4-5 years of experience in software quality assurance, preferably in the medical device industry.
• Strong understanding of quality standards and regulatory requirements.
• Experience with tools for software development, testing, and maintenance.

Responsibilities

• Develop and maintain software quality assurance processes.
• Ensure adherence to regulatory standards and industry practices.
• Support audits and inspections by regulatory bodies.

Skills

Software quality assurance

Regulatory compliance (FDA, ISO 13485)

Non-product software validation

Computer system validation (CSV)

Education

Bachelor's degree in engineering, Science or related technical field

Tools

JIRA

JAMA

Job description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Job Description:

• Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
• Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
• Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
• Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
• Creation and review of validation deliverables including but not limited to.

Responsibilities:

• Requirement Specifications (User, Functional).
• Plan.
• Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
• Traceability Matrix.
• Periodic Reviews.
• Execution of Dry/Test protocol run.
• Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
• Perform System Retirement/Decommissioning of systems not in business .
• Work closely with software development and IT teams to establish best practices for quality and compliance.
• Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
• Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.

Requirements:

• A Minimum bachelor's degree in engineering, Science or related technical field.
• Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
• Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
• Experience with non-product software validation, including tools for development, testing, and maintenance.
• Good knowledge and experience of CSV activities but not limited to.
• GxP and 21 CFR Part 11 applicability/criticality assessment.
• Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
• Execution of Dry/Test protocols.
• Conduct Periodic Reviews of systems.
• Perform System Retirement of systems that are not in business.
• Understanding of Medical Device Quality and Compliance.
• Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
• Working experience in Product Lifecycle Management (PLM) too.
• sound knowledge of computer system development lifecycles.
• Knowledge of JIRA, JAMA software and test automation is a plus. "
• Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.

Additional Information

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