What are the responsibilities and job description for the Software Quality Engineer position at TekOne IT Services Pvt. Ltd.?
Role: Software Quality Engineer
Location: Irving, TX - 75038
Duration: 10 Months
Shift Timings: 8 AM to 5 PM
Job Description
This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized
Duties
Location: Irving, TX - 75038
Duration: 10 Months
Shift Timings: 8 AM to 5 PM
Job Description
This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized
Duties
- 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.
- Performs other related duties and responsibilities, on occasion, as assigned.
- BS Degree in Engineering or Technical Field or equivalent experience.
- 2-5 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.
- 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.
- 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 timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel including internationally.
- Ability to maintain regular and predictable attendance
- 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 – TrackWise/ComplainceWire/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
