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Senior Design Quality Assurance Manager

2 months ago

North Chicago, Illinois, United States Michael Page Full time

About the Role:

The Senior Design Quality Engineer will be responsible for overseeing and driving quality assurance activities throughout the design and development lifecycle of medical devices. This role involves collaborating with cross-functional teams to ensure compliance with regulatory requirements, industry standards, and internal quality metrics.

Key Responsibilities:

  • Design Control Management: 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.
  • Risk Management: 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.
  • Regulatory Compliance: Ensure all design and development activities adhere to applicable regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR) and industry best practices. Prepare and review documentation for regulatory submissions and audits.
  • Quality Assurance: Develop, implement, and monitor quality assurance processes and procedures. Conduct and manage internal and external audits to ensure adherence to quality standards.
  • Cross-Functional Collaboration: Work closely with R&D, Manufacturing, and other departments to integrate quality considerations into the design process. Provide guidance and support to teams on quality issues and best practices.
  • Documentation and Reporting: Create and maintain comprehensive design history files (DHFs), including design plans, risk management files, and validation reports. Prepare and present quality metrics and reports to management.
  • Continuous Improvement: Lead and participate in continuous improvement initiatives aimed at enhancing product quality and process efficiency. Identify and implement best practices and lessons learned from previous projects.

Requirements:

  • Education: Bachelor's degree in Engineering, Biomedical Engineering, or a related field. Master's degree or advanced certification (e.g., CQE) is a plus.
  • Experience: 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.
  • Technical Skills: In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards. Proficiency in design control processes, risk management methodologies, and quality assurance practices.
  • Problem-Solving: Excellent analytical and problem-solving skills with the ability to navigate complex issues and develop effective solutions.
  • Communication: Strong written and verbal communication skills with the ability to interact effectively with cross-functional teams and external stakeholders.
  • Leadership: Proven leadership abilities with experience mentoring and guiding junior engineers and quality professionals.