Open Position

Quality Assurance Manager

  • Burnsville, MN

Basic Function

The Quality Assurance Manager is responsible for the quality assurance functions, ensuring compliance with Good Manufacturing Practices, Good Documentation Practices, Standard Operating Procedures, and other relevant policies, procedures, and regulations. This role involves managing the quality assurance team, conducting internal and external audits, leading cross-functional process improvement initiatives, and working closely with clients and stakeholders to maintain high-quality standards.

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  • Hires, trains, and manages skilled staff to ensure high performance and accountability, collaboration, respect for diversity, and employee job satisfaction
  • Interprets government regulations, agency guidelines, industry standards, and internal policies to ensure compliance
  • Partners with management across departments to lead quality initiatives to develop and maintain a high performing, scalable, and compliant quality system
  • Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits
  • Manages electronic quality management system including document control and training activities
  • Provides Quality Engineering leadership to directly support  medical device manufacturing
  • Leads manufacturing process development, process validation, monitoring, and improvement activities
  • Maintains equipment program including qualification, calibration, and maintenance
  • Manages nonconformance and CAPA systems
  • Produces and analyzes trend metrics and establishes necessary actions
  • Develops, recommends, and implements major changes in quality policies and procedures
  • Manages supplier evaluation, selection, and control, including supplier audits
  • Performs other related duties and responsibilities, as assigned


  • Bachelor’s degree in engineering or technical field
  • 8+ years of related work experience in roles of increasing responsibility, impact, and scope in a manufacturing environment or an equivalent combination of education and work experience
  • 3+ years experience managing people
  • Class III or Class II medical device experience strongly preferred
  • Must have experience across a broad range of quality assurance activities including a working knowledge of functions such as quality systems, document control, nonconformance and CAPA management, quality engineering, supplier management, microbiology, product and process design, and regulatory compliance
  • Comprehensive knowledge of GMP, ISO 13485, 21 CFR 820
  • Strong communication, analytical, and problem-solving skills
  • Demonstrated ability to effectively manage multiple projects and priorities
  • Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat
Imricor is an equal opportunity employer and encourages diverse candidates to apply.