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Sunnyvale, CA 94086

Posted: 03/24/2023 Job Category: Project / Program / Product Management & Architecture Job Number: 19047789

Job Description

Primary Skills: Quality Engineering, CAPAs, Process improvement, Medical Device 
Contract Type: W2 only
Duration: 12 months
Location: Sunnyvale, CA
Pay Range: $60 - $65 per hour
NOTE: Role open to Women Back to Work candidates with a career gap

TALK to a recruiter NOW: CONTACT Waseem Khan at (408) 512-2364
Work for a market leader!
  • Reporting to the Sr. Manager, Continuous Improvement Quality Engineering, the Sr. Continuous Improvement Engineer is responsible for creating and supporting a quality culture by driving activities across the organization to manage continuous process/quality improvement programs that strongly align with ISI standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
  • S/he will lead CAPAs and collaborate with subject matter experts on various activities in addition to supporting other improvement initiatives.
  • S/he will evolve existing processes/systems to ensure timely escalation identification of product quality & compliance issues within a closed loop quality management system.
  • Work to collect and analyze data, drive rigorous root cause analyses and facilitate cross-functional discussions to ensure we are seeing 'all the way around' issues for complete resolution.
  • S/he will lead internal audits as necessary.

  • Minimum Bachelor's Degree in engineering or a related field
  • Minimum 8+ years of progressive hands-on experience; or equivalent combination of education and experience.
  • Knowledge of Quality Systems Regulations (21 CFR 820), ISO 13485 and ISO 14971 preferred.
  • Knowledge and hand on experience with Process improvement tools and methodologies (Lean, Six Sigma). Green or Black Belt Certification in Lean or Six Sigma is preferred.
  • Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and desired business results.
  • Ability to travel up to 10% of the time.
CALL NOW: Waseem Khan at (408) 512-2364

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 2022 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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