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Sunnyvale, CA 94086

Posted: 01/30/2023 Job Category: Quality Assurance and Testing Job Number: 18696307

Job Description

Primary Skills: Quality Engineering, CFR 21 820/ISO 13485, Risk, Medical Device industry, Six Sigma
Duration:  11 Months with high possible extension
Location: Sunnyvale, CA
Contract Type: W2
Pay-Range: $55- $65/hr on w2

TALK to a recruiter NOW: CONTACT Pallavi at 408-816-2464

Work for a market leader! 
  • Lead product nonconformance investigation, such as robotic assemblies not performing to specification and component out of tolerance. For each nonconformance investigation this quality engineer will also lead the assessment of usage risk. This Quality Engineer will also support the determination of root cause and countermeasures to prevent recurrence of the nonconformance.
  • Analyze internal and external product data to identify improvement opportunities, initiate projects that will improve the quality of the Intuitive products.
  • Monitor quality metrics. Present quality metrics to management team and operation team, pinpoint the areas that need improvement.
  • Quality Systems & Risk Management: Navigates quality system independent of oversight. Develops project plans including the proposed quality system risks & benefits. Makes updates to improve quality systems and mentor others. Analyzes RMAs, QNs and make the necessary updates to risk documents.
  • Compliance- Able to articulate the latest and complex regulation to project team. Able to understand the impact of regulations to our procedures and make the corresponding SOP/DOP updates. Able to contribute in external audits, perform internal audits.
  • Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics.
  • 5+ years of working experience in Quality Engineering or related field, minimum 3 years in medical device design or manufacturing environment.
  • Able to navigate quality and compliance system with minimal oversight on individual projects.
  • Demonstrated Understanding of CFR 21 820/ ISO 13485 requirements for making process or design changes.
  • Understands product risks, able to generate FMEA and have good grasp of quality control and tools.
  • Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
CALL NOWPallavi at 408-816-2464

Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. Akraya was recently voted as a 2021 Best Staffing Firm to Temp For by Staffing Industry Analysts and voted by our employees and consultants as a 2022 Glassdoor Best Places to Work. 

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