Senior Software Quality Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Irving, TX 75061
Description:
Responsibilities:
Requirements:
- 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.