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Senior Design Quality Assurance Specialist

2 months ago

North Chicago, Illinois, United States Michael Page Full time
{"title": "Senior Design Quality Assurance Specialist", "content": "Job Summary

We are seeking a highly experienced Senior Design Quality Assurance Specialist to join our team at Michael Page. As a key member of our quality assurance team, you will be responsible for overseeing and driving quality assurance activities throughout the design and development lifecycle of medical devices.

Key Responsibilities
  • Lead and support design control activities, including design inputs, design outputs, design reviews, verification and validation, and design transfer to ensure compliance with FDA regulations and ISO 13485 standards.
  • Oversee risk management processes, including Hazard Analysis and Critical Control Points (HACCP), Failure Mode and Effects Analysis (FMEA), and Fault Tree Analysis (FTA) to identify, assess, and mitigate potential risks associated with medical device design and development.
  • Ensure all design and development activities adhere to applicable regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR) and industry best practices.
  • Develop, implement, and monitor quality assurance processes and procedures.
  • Conduct and manage internal and external audits to ensure adherence to quality standards.
Requirements
  • Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
  • Minimum of 7-10 years of experience in quality engineering within the medical device industry, with a strong focus on design controls and regulatory compliance.
  • In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
  • Excellent analytical and problem-solving skills with the ability to navigate complex issues and develop effective solutions.
  • Strong written and verbal communication skills with the ability to interact effectively with cross-functional teams and external stakeholders.
What We Offer
  • Compensation up to $120,000.
  • 6% 401K match.
  • 10% Bonus.
  • 3 weeks PTO.
  • Health, Dental and Vision (BCBS).
", "lang_code": "en-US"}