Computer System ValidationKatalyst HealthCares & Life Sciences • Santa Clara, CA
Computer System Validation
Katalyst HealthCares & Life Sciences • Santa Clara, CA
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]A Minimum bachelor's degree in engineering, Science or related technical field. Minimum of - years of experience in software quality assurance or software validation, preferably within the medical device industry. Strong understanding of quality standards and regulatory requirements (, FDA CFR Part , ISO , IEC ). 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 CFR Part 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 protocol. Conduct Periodic Reviews of system. Perform System Retirement of systems that are not in business. Understanding of Medical Device Quality and Compliance. Good knowledge of GxP, GAMP and CFR Part guidelines. Working experience in Product Lifecycle Management (PLM) tool. Sound knowledge of computer system development lifecycles Knowledge of JIRA, JAMA software and test automation is a plus. "
Responsibilities :
- Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
- Ensure adherence to regulatory standards (FDA, ISO , IEC ) 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 CFR Part .
- Creation and review of validation deliverables including but not limited to.
- Requirement Specifications (User, Functional).
- Plan.
- Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
- Traceability Matrix.
- Periodic Reviews.
- System Retirement / Decommissioning.
- 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 :
[job_alerts.create_a_job]
Validation • Santa Clara, CA
[internal_linking.similar_jobs]
Part-Time Computer Applications Instructor (Pool).PART-TIME, ASSOCIATE FACULTY POOL.Applications for Part-Time, Associate Faculty pools are continually accepted (unless otherwise specified) by the ...[show_more]
Our client, a Medical Center facility under the aegis of a California Public Ivy university and one of largest health delivery systems in California, seeks an accomplished.EPIC Cadence Applications...[show_more]
Working within Bio-Rad's Life Science R&D Group as a Systems Engineer, you will take engineering concepts, requirements and transform them into functional prototypes and finished products that impr...[show_more]
Telecare's mission is to deliver excellent and effective behavioral health services that engage individuals in recovering their health, hopes, and dreams.
Telecare continues to advance cultural dive...[show_more]
CROSS Practitioner in Residence (Junior, Assistant, Associate and Specialist ranks) .Commensurate with qualifications and experience.
Represented Specialist Series Fiscal Year.A reasonable estima...[show_more]
This is a temporary position and the length of assignment is estimated to go through July 2026.The length of the assignment is always dependent on business need and dates may change.While the assig...[show_more]
A leading engineering firm is seeking an Embedded Software Validation Engineer in California.The role involves creating automated tests for automotive firmware and applications while collaborating ...[show_more]
Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop / Big Data, Hyperscale, HPC and IoT / Embedded customers...[show_more]
As a Senior Software Simulation Validation Engineer, you will be a technical leader responsible for ensuring the quality and reliability of autonomous vehicle simulation platforms.The role bridges ...[show_more]
If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...[show_more]
AlliedTravelCareers is working with Medical Solutions to find a qualified Physical Therapy Assistant (PTA) in Santa Cruz, California, 95060!.
A facility in Santa Cruz, CA is seeking its next amazing...[show_more]
We are seeking a highly skilled.Oracle Fusion Financials and Enterprise Performance Management (EPM) Consultant.The ideal candidate will have hands-on experience implementing, supporting, and optim...[show_more]
Our platform combines sensing, embedded systems, AI, and hardware deployed in real clinical environments.Hardware Systems & Test Engineer.
This role sits at the intersection of.QA, system integr...[show_more]
We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more]
Welcome to the Post-Silicon Validation Team at Cisco! Ourgroup offers a unique combination of a startup culture with the benefits of working for the leading networking company in the world.You will...[show_more]
PsiQuantum'smission is to build the first useful quantum computers-machines capable of delivering the breakthroughs the field has long promised.
Since our founding in 2016, our singular focus has be...[show_more]
We have partnered with a large health system in the Northeast to identify a System Chief of Cardiovascular Imaging.This is a new role for the system and will work closely with the System Chief of C...[show_more]
Focus Staff is seeking a travel Physical Therapist for a travel job in Capitola, California.Job Description & Requirements.
The ideal candidate will have at least 1 year of experience in a PT settin...[show_more]
Part-Time Computer Applications Instructor (Pool)
InsideHigherEd • Saratoga, California, United States
[job_card.part_time]
[last_updated.last_updated_30] • [promoted]
EPIC Cadence Analyst (REMOTE / NO C2C)
Amerit Consulting • Fremont, CA, United States
[filters.remote]
[job_card.permanent]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Staff Systems Engineer
Bio-Rad Laboratories • Pleasanton, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Recovery Specialist II (On Call) - Behavioral Health 194 195
Telecare Corporation • Santa Cruz, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Computer Science and Engineering Department : CROSS Practitioner in Residence Pool
University of California - Santa Cruz • Santa Cruz, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Risk Adjustment Coding Educator (Temporary)
Central California Alliance for Health • Scotts Valley, CA, United States
[job_card.full_time] +2
[last_updated.last_updated_1_day] • [promoted]
Senior Automotive Embedded Validation Engineer
Yoh, A Day & Zimmermann Company • Palo Alto, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
System Validation Engineer
Supermicro • San Jose, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Senior Software Engineer - Simulation Validation
General Motors • Sunnyvale, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
IRT eCOA Systems Manager
Jazz Pharmaceuticals • Fremont, California, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Travel Physical Therapy Assistant (PTA) - $1,805 per week in Santa Cruz, CA
AlliedTravelCareers • Santa Cruz, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Principal Business System Analyst
Cloud Software Group, Inc. • San Ramon, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Hardware Systems & Test Engineer
Shyld AI • Fremont, CA, US
[job_card.full_time]
[last_updated.last_updated_less] • [promoted] • [new]
Remote Financial Advising Expert - AI Trainer ($50-$60 / hour)
Data Annotation • Santa Cruz, California
[filters.remote]
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
SW Post-Silicon Validation Engineer
Cisco Systems, Inc. • San Jose, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Senior Subsystem Validation Engineer
PsiQuantum • Milpitas, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
System Chief | Cardiovascular Imaging | Northern PA
Jackson Physician Search • Danville, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Travel Rehabilitation Physical Therapist - $2,304 per week
Focus Staff • Capitola, CA, United States
[job_card.permanent]
[last_updated.last_updated_variable_days] • [promoted]