Katalyst Healthcares and Life Sciences
Senior Software Quality Engineer
Katalyst Healthcares and Life Sciences, Irving, Texas, United States, 75084
Responsibilities:
This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division. Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. Create and execute or direct software validation protocols traceable to system/software requirements. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks. Design and implement various product and process improvement methodologies (i.e. Six Sigma and Lean Manufacturing). Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues. Software scoping and Part 11 audits. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in a timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 5-25%, including internationally. Ability to maintain regular and predictable attendance. Requirements:
Bachelor's with 8+ years of experience or master's with 5+ years of experience. At least 7 years Software Quality Engineering experience. Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing skills. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. Experience working in a broader enterprise/cross-division business unit model preferred. Prior experience in regulated industry - GxP systems. Good knowledge of FDA regulations; 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485 and ISO 27001. Quality Management Tools and Test Management Tools - Track Wise/Compliance Wire/Veeva, ALM, JIRA etc., Knowledge about Data Integrity and prior audit support experience (Internal/External). Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS) and Custom applications. Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications - Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc., Collaborate with the cross functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met. Review of CAPAs, Change Controls and Defects for GxP applications. Working with Global teams and providing audit support. Working with a range of applications/tools including ALM, Track Wise, JIRA, Confluence, and other integration tools.
This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division. Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. Create and execute or direct software validation protocols traceable to system/software requirements. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks. Design and implement various product and process improvement methodologies (i.e. Six Sigma and Lean Manufacturing). Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues. Software scoping and Part 11 audits. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in a timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 5-25%, including internationally. Ability to maintain regular and predictable attendance. Requirements:
Bachelor's with 8+ years of experience or master's with 5+ years of experience. At least 7 years Software Quality Engineering experience. Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing skills. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. Experience working in a broader enterprise/cross-division business unit model preferred. Prior experience in regulated industry - GxP systems. Good knowledge of FDA regulations; 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485 and ISO 27001. Quality Management Tools and Test Management Tools - Track Wise/Compliance Wire/Veeva, ALM, JIRA etc., Knowledge about Data Integrity and prior audit support experience (Internal/External). Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS) and Custom applications. Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications - Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc., Collaborate with the cross functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met. Review of CAPAs, Change Controls and Defects for GxP applications. Working with Global teams and providing audit support. Working with a range of applications/tools including ALM, Track Wise, JIRA, Confluence, and other integration tools.