What are the responsibilities and job description for the Senior Software Quality Engineer position at Global Technical Talent, an Inc. 5000 Company?
Primary Job Title:
Senior Software Quality EngineerAlternate/Related Job Titles:
- Software Validation Engineer
- Quality Systems Engineer
- Software Verification & Validation Engineer
- Risk & Compliance Quality Engineer
Pleasanton, CAOnsite Flexibility:
OnsiteContract Details:
- Position Type: Contract
- Contract Duration: 12 months
- Start: As Soon As Possible (target 11/03/2025)
- Pay Rate: $56.04 per hour
- Shift: 8:00 AM - 5:00 PM (Pacific Time)
- Schedule: Monday - Friday
- Hours per Week: 40
- 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.
- 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.
- 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.
- 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
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
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
Salary : $56