Senior Design Quality Assurance Specialist

6 days ago


Chicago, Illinois, United States Michael Page Full time
Job Title: Senior Design Quality Engineer

We are seeking a highly experienced Senior Design Quality Engineer to join our team at Michael Page. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards are met throughout the design and development lifecycle of our 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, such as FDA, ISO 13485, MDD/MDR, and industry best practices.
  • Develop, implement, and monitor quality assurance processes and procedures, and conduct and manage internal and external audits to ensure adherence to quality standards.
  • Work closely with R&D, Manufacturing, and other departments to integrate quality considerations into the design process, and provide guidance and support to teams on quality issues and best practices.
  • Create and maintain comprehensive design history files (DHFs), including design plans, risk management files, and validation reports, and prepare and present quality metrics and reports to management.
Requirements:
  • Bachelor's degree in Engineering, Biomedical Engineering, or a related field, with a Master's degree or advanced certification (e.g., CQE) preferred.
  • 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, and proficiency in design control processes, risk management methodologies, and quality assurance practices.
  • 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.
  • Proven leadership abilities, with experience mentoring and guiding junior engineers and quality professionals.
What We Offer:
  • Compensation up to $120,000
  • 6% 401K match
  • 10% Bonus
  • 3 weeks PTO
  • Health, Dental, and Vision (BCBS)
  • Hybrid work schedule

At Michael Page, we are committed to providing a diverse and inclusive work environment, and we welcome applications from qualified candidates from all backgrounds. If you are a motivated and experienced Senior Design Quality Engineer looking for a new challenge, please submit your application today.



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