Quality Engineer

3 days ago

Murrysville, United States Intellectt Inc Full time

Hi All,


One of my clients is looking Role: Quality Engineer, if you’re interested or your skills matches, please share with me your updated resume to sohail@intellectt.com


Job Title: Quality Engineer

Location: Staunton, VA

Client: Medical Device Company

Visa: Green Card or U.S. Citizen


Note: No C2C


Position Summary

Cadence is seeking a Quality Engineer to join our team in Staunton, VA. This role is essential for ensuring product quality and safety in compliance with medical device regulations. The Quality Engineer will analyze and optimize processes to enhance quality performance, reduce defects, and ensure adherence to industry standards.


Key Responsibilities

  • Quality Assurance: Ensure all products meet the required quality and safety standards in compliance with FDA regulations and ISO standards.
  • Process Improvement: Analyze manufacturing processes and implement improvements to enhance quality performance and reduce defects.
  • Risk Management: Conduct risk assessments and facilitate Failure Mode and Effects Analysis (FMEA) to identify potential quality issues.
  • Corrective Actions: Proactively identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPAs).
  • Documentation: Prepare and review quality documentation, including validation protocols, quality plans, and inspection reports.
  • Cross-Functional Collaboration: Work closely with engineering, production, and regulatory teams to address quality concerns and ensure compliance.
  • Training and Development: Support training initiatives to promote quality awareness and compliance within the organization.


Qualifications

  • Bachelor’s degree in Engineering, Quality Assurance, or a related field.
  • 3+ years of experience in quality engineering, preferably in the medical device industry.
  • Strong understanding of FDA regulations, ISO 13485, and quality management systems.
  • Proficient in statistical analysis and quality improvement methodologies (e.g., Six Sigma, Lean).
  • Excellent problem-solving skills and attention to detail.
  • Strong communication skills and ability to work collaboratively in a team environment.

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