What are the responsibilities and job description for the Software Quality Engineer with Pharma Client exp - Irving, TX (Onsite) (GC and USC only) position at Smart Caliber Technology?
Position: Software Quality Engineer
Duration: 12 Months
Location: Irving, TX (Onsite)
Position Overview
We are seeking a highly skilled and experienced Software Quality Engineer to execute and maintain software quality engineering methodologies and provide quality engineering support for software used throughout the division. This role is critical in ensuring compliance and supporting Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Responsibilities
Vishal
vishal@smartcaliber.com
www.smartcaliber.com
Truth Lies in Heart
Duration: 12 Months
Location: Irving, TX (Onsite)
Position Overview
We are seeking a highly skilled and experienced Software Quality Engineer to execute and maintain software quality engineering methodologies and provide quality engineering support for software used throughout the division. This role is critical in ensuring compliance and supporting Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Responsibilities
- Develop and conduct training on software development and validation programs for company personnel.
- Collaborate with Design and Manufacturing Engineering to fulfill system/software requirements and verification/validation processes.
- Create and execute software validation protocols traceable to system/software requirements.
- Implement and oversee solutions for code control and software event/defect tracking systems.
- Complete and maintain risk analysis with a focus on software-related risks.
- Design and apply product and process improvement methodologies, including Six Sigma and Lean Manufacturing.
- Use systematic problem-solving techniques to prioritize, communicate, and resolve issues effectively.
- Support software scoping and perform Part 11 audits.
- Ensure compliance with FDA regulations and other regulatory requirements.
- Collaborate effectively across teams, including Global teams, and provide audit support as needed.
- Review and approve Software Lifecycle (SLC) deliverables, CAPAs, Change Controls, and Defects for GxP applications.
- Work with applications/tools such as ALM, TrackWise, JIRA, Confluence, and other integration tools.
- Bachelor’s degree in Engineering or Technical field with 8 years of experience, or a Master’s degree with 5 years of experience.
- Minimum of 7 years of experience in Software Quality Engineering.
- Advanced knowledge of FDA regulations (21 CFR Part 11, 820, Annex 11), GxP systems, GAMP5, ISO 13485, and ISO 27001.
- Proficiency in Quality and Test Management tools, such as TrackWise, ComplianceWire, Veeva, ALM, JIRA.
- Strong computer skills, including statistical/data analysis, report writing, and data mining.
- Prior experience in a regulated industry (medical device experience preferred).
- Familiarity with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), COTS, and custom applications.
- ASQ CSQE certification is a plus.
- Strong organizational, communication, and multitasking skills.
- Ability to work both independently and collaboratively within a matrixed, cross-functional team.
- Willingness to travel approximately 5-25%, including internationally.
Vishal
vishal@smartcaliber.com
www.smartcaliber.com
Truth Lies in Heart
