Job Description
Primary Skills:
Quality Engineering (Expert), Failure Analysis (Advanced), cGMP (Advanced), Regulatory Compliance (Advanced) Data Analysis (Expert) Contract Type:
W2 Duration:
12 Months Location:
Santa Clara, CA - 95054 (Onsite) Pay Range:
$55 - $60 per hour on W2 Job Summary:
We are seeking an experienced Quality Engineer III to join a leading bioprocess automation equipment organization in Santa Clara, CA. This role will be responsible for independently leading complex quality investigations, managing CAPAs, supporting customer complaint investigations, and driving continuous improvement initiatives within a regulated manufacturing environment. The ideal candidate will possess strong root cause analysis expertise, quality systems knowledge, and the ability to collaborate cross-functionally with manufacturing, engineering, supplier quality, and service teams. Key Responsibilities:
Lead end-to-end CAPA activities including investigations, root cause analysis, corrective actions, and effectiveness verification. Conduct structured root cause analysis using methodologies such as 8D, 5 Whys, Fishbone, and data-driven investigation techniques. Drive customer complaint investigations, product failure analysis, and risk assessments. Collaborate with Manufacturing, Engineering, Supplier Quality, and Service teams to resolve quality issues. Support nonconformance investigations, product containment decisions, and supplier corrective action activities (SCARs). Analyze quality trends across CAPA, complaints, and nonconformance systems to identify improvement opportunities. Support audits, inspections, and quality system reviews. Develop and improve procedures, work instructions, and quality system processes. Contribute to Lean, PPI, and Six Sigma continuous improvement initiatives. Mentor team members on investigation techniques and structured problem-solving practices. Must-Have Skills:
5-8 years of Quality Engineering experience within regulated industries. Strong experience with CAPA, nonconformance investigations, and customer complaint handling. Hands-on expertise in Root Cause Analysis methodologies (8D, 5 Whys, Fishbone, etc.). Knowledge of ISO 9001, ISO
13485, and cGMP environments. Experience working cross-functionally with Manufacturing, R D, and Supplier Quality teams. Strong analytical, documentation, and technical communication skills. Ability to independently manage multiple complex investigations simultaneously. Bachelor's degree in Engineering or related technical discipline. Industry Experience:
Medical Devices/ Life Sciences/ Pharmaceutical Manufacturing/ Bioprocess Automation ABOUT AKRAYA
Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment . Most recently, we were recognized Stevie Employer of the Year 2025, SIA Best Staffing Firm to work for 2025, Inc 5000 Best Workspaces in US (2025 & 2024) and Glassdoor's Best Places to Work (2023 & 2022)! Industry Leaders in Tech Staffing As Talent solutions provider for Fortune 100 Organizations, Akraya's industry recognitions solidify our leadership position in the IT staffing space. We don't just connect you with great jobs, we connect you with a workplace that inspires! Join Akraya Today! Let us lead you to your dream career and experience the Akraya difference. Browse our open positions and join our team!
