Senior Software Quality Engineer - Katalyst Healthcares & Life Sciences

• 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.