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Senior Design Assurance Engineer

2 months ago

Pittsburgh, Pennsylvania, United States Comtec Consultants Full time
Job Summary

We are seeking a highly skilled Senior Design Assurance Engineer to join our team at Comtec Consultants. As a key member of our Quality Engineering department, you will be responsible for ensuring the quality and reliability of our products throughout their lifecycle.

Key Responsibilities
  • Develop and implement quality plans and processes to ensure compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to design and develop high-quality products that meet customer needs and expectations.
  • Conduct design reviews and assessments to identify potential quality issues and implement corrective actions.
  • Lead root cause analysis and quality problem-solving initiatives to resolve product defects and quality issues.
  • Develop and maintain quality engineering documents, including design controls, hazard analysis, and design verification and validation plans.
  • Provide training and guidance to junior quality engineers and other team members on quality engineering principles and practices.
  • Collaborate with regulatory affairs specialists to ensure compliance with regulatory requirements and industry standards.
Requirements
  • Bachelor's degree in engineering or a related field.
  • Minimum 3 years of experience in quality engineering or a related field, preferably in a medical device or regulated industry.
  • Working knowledge of design controls, hazard analysis, and design verification and validation processes.
  • Strong understanding of quality management principles and practices, including ISO 13485 and FDA regulations.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Ability to analyze complex data and identify quality issues and opportunities for improvement.