[ref. b97985402] Senior Quality Systems Validation Engineer
Advanced Bionics LLC Valencia
HOURS: Full-time, 40 hours per week
SALARY: $114,754-$133,500 per year
Participate in the management and improvement of software quality assurance and quality systems validation practices and procedures. Develop and prepare requirements, protocols, and reports for software system validation for the Receiving Inspection department as deliverables.
Design and develop software validation plans, perform software validation tests of new and existing systems, and document methodologies for test cases, installation and operational qualifications, and performance qualifications. Review and coordinate all software validation and debugging activities, and oversee validation area processes and procedures.
Responsible for commissioning and qualification of facilities, including testing and troubleshooting, documentation, and adherence to regulatory standards to ensure product quality, safety, and compliance. Create, develop, and modify specialized software systems (from local to enterprise level) to maintain and enhance quality records, utilizing SQL and other programming languages.
Collaborate with programmers and analysts in defining product requirements to identify test scenarios and performance limits. Review and analyze database design in the planning, development, implementation, and maintenance of software applications, design mitigation strategies, and contingency processes.
Review and identify the discrepancies between actual performance and documented specifications. Store, retrieve, and track the resolution of software data, defects, and system capabilities. Review and modify access database software systems to fit specific user needs and workstations, and document methods used for various test cases.
Plan and conduct audits, and provide recommendations for retraining and/or methods for improvement where necessary (tooling, gauges, fixtures). Identify and mitigate risks associated with medical device software through risk assessment and risk management processes.
Perform process and test method validation to ensure product quality and regulatory requirements are met. Coordinate software system installation, create reports on the status of systems, and provide the validation projects portfolio to managers.
Utilize SQL, Oracle 10g, Visual Basic and Visual Basic Scripting Edition (VBScript), BarTender, and Loftware software to design and create automated labels from database systems. Maintain competence with medical device regulations, requirements, and industry trends for computerized system validation, including ISO 13485, 21 CFR 820, 21 CFR Part 11, cGMP, and GAMP-5.
Participate in the change control process, revising test specifications and protocols to implement changes to determine adequacy and correctness, and validate changes to ensure they are correctly incorporated into the software products. Perform equipment qualification to ensure that the equipment operates reliably and consistently, according to predefined specifications.
Conduct trend analysis on historical data to identify process improvement opportunities. Provide training for new inspectors in areas related to quality systems, inspection methods, test automation, sampling plans, and equipment. Undertake special assignments as directed by management.
SALARY: $114,754-$133,500 per year
EMPLOYER: Advanced Bionics LLC
28515 Westinghouse PlaceValencia, CA 91355
Job Duties:
Responsible for the administration, planning, and monitoring of verification and validation activities for quality systems software that is used for achieving operational excellence within quality assurance processes and to ensure quality standards are being met in the healthcare industry.Participate in the management and improvement of software quality assurance and quality systems validation practices and procedures. Develop and prepare requirements, protocols, and reports for software system validation for the Receiving Inspection department as deliverables.
Design and develop software validation plans, perform software validation tests of new and existing systems, and document methodologies for test cases, installation and operational qualifications, and performance qualifications. Review and coordinate all software validation and debugging activities, and oversee validation area processes and procedures.
Responsible for commissioning and qualification of facilities, including testing and troubleshooting, documentation, and adherence to regulatory standards to ensure product quality, safety, and compliance. Create, develop, and modify specialized software systems (from local to enterprise level) to maintain and enhance quality records, utilizing SQL and other programming languages.
Collaborate with programmers and analysts in defining product requirements to identify test scenarios and performance limits. Review and analyze database design in the planning, development, implementation, and maintenance of software applications, design mitigation strategies, and contingency processes.
Review and identify the discrepancies between actual performance and documented specifications. Store, retrieve, and track the resolution of software data, defects, and system capabilities. Review and modify access database software systems to fit specific user needs and workstations, and document methods used for various test cases.
Plan and conduct audits, and provide recommendations for retraining and/or methods for improvement where necessary (tooling, gauges, fixtures). Identify and mitigate risks associated with medical device software through risk assessment and risk management processes.
Perform process and test method validation to ensure product quality and regulatory requirements are met. Coordinate software system installation, create reports on the status of systems, and provide the validation projects portfolio to managers.
Utilize SQL, Oracle 10g, Visual Basic and Visual Basic Scripting Edition (VBScript), BarTender, and Loftware software to design and create automated labels from database systems. Maintain competence with medical device regulations, requirements, and industry trends for computerized system validation, including ISO 13485, 21 CFR 820, 21 CFR Part 11, cGMP, and GAMP-5.
Participate in the change control process, revising test specifications and protocols to implement changes to determine adequacy and correctness, and validate changes to ensure they are correctly incorporated into the software products. Perform equipment qualification to ensure that the equipment operates reliably and consistently, according to predefined specifications.
Conduct trend analysis on historical data to identify process improvement opportunities. Provide training for new inspectors in areas related to quality systems, inspection methods, test automation, sampling plans, and equipment. Undertake special assignments as directed by management.
Domestic and international travel (California, Switzerland, Germany, Mexico) to manufacturing sites and office locations (up to 10%). May work from home anywhere within the United States. Reports to the Advanced Bionics LLC office in Valencia, CA.
Requirements:
- Masters degree in Computer and Information Technology, Computer Science, Information Technology Management, or a related field, and 2 years of experience as a Validation Engineer or a related occupation in the healthcare industry.
- Must have experience with the following:
- Software Validation
- cGMP Requirements
- Equipment Qualification
- Process and Test Method Validation
- Discrepancies and Deliverables
- Installation and Operational Qualifications
- Performance Qualifications
- Testing and Troubleshooting
- Domestic and international travel (California, Switzerland, Germany, Mexico) to manufacturing sites and office locations (up to 10%).
- FULLY REMOTE: May work from home anywhere within the United States. Reports to the Advanced Bionics LLC office in Valencia, CA.
To Apply, Email Resume to: Attn: S. Spatrisano-Saenz/RE: SQSVE
Scarlett.Spatrisano-Saenz@advancedbionics.com
EA Brand GroupLos Angeles, 39 mi from Valencia (CA)
Job Summary
Our team has an exciting opportunity for a Validation Engineer III for a well established pharmaceutical manufacturing company. The candidate will be responsible for testing (measure, analyze, and verify specifications) the equipment...
Valencia (CA)
Just off Freeway 5, minutes from Six Flags Magic Mountain theme park, and less than 45 minutes from downtown Los Angeles, this all-suite hotel in Valencia, CA offers contemporary comfort and excellent service.
Guests can get a bright start to the day...
Sonova AGValencia (CA)
Who we are
In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To...
Best jobs you don't want to miss: