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Quality Engineer

Santa Clara, CA 95054

Posted: 06/26/2026 Industry: Engineering Job Number: 26-88324 Pay Rate: 56.5-56.5 USD/Hour

Job Description

Shift: Monday-Friday, 1st shift hours
Duration: 12 Months
Pay range: $56.50 Hourly - $56.50 Hourly 
Onsite
 Summary:
  • This candidate will work closely with cross functional teams to write, edit, review and finalize technical documents to support design transfer activities.
  • The individual will write or process, and implement all quality documents related to design transfer activities including procedure change orders and document change orders to reflect approved changes.
  • Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented.
Key Responsibilities: 
  • Write and provide guidance in Design Transfer documentation
  • Technically strong to work independently with R&D and various scientists to transfer information from technical transfer memorandum from an early Design Control phase into brand new work instructions.
  • Designs a new layout for SOPs relating to Manufacturing production/process instructions, policies, and procedures
  • Creates part numbers and Bill of Materials into the Material Resource Planning (MRP) software
  • Lead cross functional documentation projects as required
  • Support Senior Scientists in corrective and preventive actions for technical issues to ensure timely and accurate documentation of root cause analysis
  • Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance
  • Requirements/Qualifications:
  • BS/MS in a scientific discipline with 5-10 years diagnostic industry experience
  • Familiarity with SAP/ ERP system.
  • Familiarity with Design Control
  • Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).
  • Knowledge of ISO 13485, FDA QSRs and GMP
  • Proofreading and editing skills, and an aptitude for numbers and detail oriented work requiring a high degree of accuracy.
  • Proactive in suggesting improvements in workflow.
  • Must have excellent customer service and listening skills.
  • Able to sit, stand and/or use keyboard for long periods of time.
  • Must have the skills to work as a strong contributor in a team effort.
  • Demonstrate good flexibility with changes to working environment and deliver high quality results in a high-pressured deadline oriented environment
  • Experience in preparing manufacturing documents including SOPs, specification sheets and worksheets.
  • Experience in IVD Manufacturing
  • familiarity with Statistical Process Controls (SPC), Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma)
 Non-Negotiable Hiring Criteria: Bachelor's degree or equivalent work experience

Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:
  • Four options of medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Other Employee Perks
About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch   

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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!