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Medical Device Quality Assurance and Regulatory Affairs Manager

1 month ago

Union, Kentucky, United States Gateway Recruiting Full time

Company Overview: As a leading recruitment agency, Gateway Recruiting is dedicated to connecting top talent with exciting career opportunities. Our commitment to excellence drives us to deliver exceptional results for our clients.

Estimated Salary Range: $120,000 - $180,000 per year

Job Description: We are seeking an experienced Quality Assurance Manager to join our client's team. In this role, you will be responsible for ensuring compliance with FDA 21CFR820, ISO13485, and EU Medical Device Regulation (EUMDR). You will lead the quality management system, develop procedures, train associates, and oversee corrective actions.

Key Responsibilities:

  • Develop and implement quality system procedures in accordance with regulatory requirements.
  • Train associates on updated procedures and ensure effective training programs.
  • Oversee Corrective and Preventive Action (CAPA) process to resolve product and process non-conformances.
  • Evaluate product and process non-conformances and provide support to production teams.
  • Liaise with regulatory affairs processes, registration, and medical device reporting.
  • Maintain an effective quality management system (QMS) to ensure delivery of high-quality products.

Required Skills and Qualifications:

  • Bachelor's degree in a relevant field or Engineering.
  • Advanced degree preferred with greater than 8 years of experience in quality systems.
  • Related experience in Medical Device FDA-regulated industry.
  • Knowledge of FDA regulations and international regulatory requirements.
  • Excellent leadership and team management skills.
  • Strong analytical and problem-solving abilities.

Benefits: Competitive salary range, comprehensive benefits package, and opportunities for professional growth and development.

Other Opportunities: Collaborate with cross-functional teams, contribute to company objectives, and advance your career in quality assurance and regulatory affairs.