What are the responsibilities and job description for the Senior Software Quality Engineer position at GTT, LLC?
Primary Job Title:
Senior Software Quality Engineer
Senior Software Quality Engineer
Alternate/Related Job Titles:
- Software Validation Engineer
- Quality Systems Engineer
- Software Verification & Validation Engineer
- Risk & Compliance Quality Engineer
Location:
Pleasanton, CA
Pleasanton, CA
Onsite Flexibility:
Onsite
Onsite
Contract Details:
- Position Type: Contract
- Contract Duration: 12 months
- Start: As Soon As Possible (target 11/03/2025)
- Pay Rate: $56.04 per hour
Shift & Schedule:
- Shift: 8:00 AM – 5:00 PM (Pacific Time)
- Schedule: Monday – Friday
- Hours per Week: 40
Job Summary:
The Senior Software Quality Engineer is responsible for executing and maintaining software quality engineering methodologies while providing risk assessment and regulatory compliance support for software systems utilized across the division. This role ensures that all software products and processes meet FDA, ISO 13485, and IEC 62304 standards. The ideal candidate will bring a strong background in software verification and validation (V&V), risk controls, and traceability matrices for medical device or healthcare software systems.
Key Responsibilities:
- Collaborate with Design and Test Engineering to complete system/software requirements and support verification and validation processes.
- Review and approve software validation protocols traceable to system and software requirements.
- Participate in and guide meetings related to software events, defects, and anomaly investigations.
- Drive the completion and maintenance of software-related risk analyses.
- Design and implement product and process improvement methodologies (e.g., Six Sigma, Lean Manufacturing).
- Apply structured problem-solving methodologies to identify, prioritize, and resolve software quality issues.
- Conduct software scoping and 21 CFR Part 11 audits for compliance.
- Support company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory frameworks.
- Ensure compliance with FDA regulations, ISO 13485, and IEC 62304 standards, as well as internal operating procedures.
- Maintain cooperative communication with internal teams, customers, contractors, and vendors.
- Perform other related duties and responsibilities as assigned.
Required Experience:
- Bachelor’s degree in Engineering, Computer Science, or a related technical field (or equivalent experience).
- Minimum 5 years of experience in Quality Engineering within the medical device or in vitro diagnostics industry.
- Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485.
- Strong computer skills, including data analysis and technical report writing.
- Prior experience working in a regulated environment (medical device or IVD).
- Excellent written and verbal communication skills, with the ability to interact effectively across all organizational levels.
- Strong organizational and time management skills with keen attention to detail.
- Ability to manage multiple priorities and meet tight deadlines in a dynamic environment.
- Must maintain regular and predictable attendance.
Nice-to-Have Experience:
- ASQ CSQE certification preferred.
- Experience working in a cross-functional enterprise environment.
- Familiarity with Six Sigma, Lean principles, or CAPA methodologies.
- Experience with software traceability, validation documentation, and risk management tools.
Required Skills:
- Software Verification & Validation (V&V)
- Risk Management & Traceability
- Quality Systems & FDA Regulatory Compliance
- ISO 13485 and IEC 62304 Expertise
- Root Cause Analysis & CAPA
- 21 CFR Part 11 Audit Knowledge
- Six Sigma & Lean Methodologies
- Cross-Functional Communication
- Data Analysis & Report Writing
- QMS and EMS Compliance
- Risk Analysis Documentation
- Project Coordination in Matrixed Teams
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About the Client:
Global Healthcare Innovator — A leading healthcare company dedicated to improving lives worldwide. The organization’s portfolio includes medical devices, diagnostics, nutrition products, and branded generics. Committed to developing groundbreaking technologies that address global healthcare challenges, it empowers people to live healthier, more fulfilling lives.
Join the team to:
Join the team to:
- Work on cutting-edge projects
- Contribute to global healthcare advancements
- Experience diverse cultures and professional growth
- Build a rewarding career with a company that cares
About GTT:
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!
Job Number: 25-27414
#LI-GTT #LI-Onsite #gttjobs
Salary : $56
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