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Quality Assurance/Regulatory Assurance Specialist

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Position Purpose:

Responsible for monitoring and implementing strategies to improve quality and regulatory compliance within the Power Assist Division. 

Key Duties: 

  • Monitor product quality at Production level
  • Monitor product quality at Customer level
  • Report KPI's to management regarding quality performance 
  • Propose root cause strategies to improve product/process quality
  • Ensure all regulatory procedures are followed and evidence accurately/timely documented 
  • Assist in the on-going maintenance/revisions of standard procedures, work instructions, and quality manual
  • Investigate complaints and lead CAPA efforts
  • Provide submissions to all applicable regulatory agencies/authorities
  • Assist in regulatory audits as needed
  • Assist in regulatory training for new employees and all staff as required by changes in the quality system and/or changes in relevant regulations

Education Requirements:

  • Associates Degree in business or another related field

Knowledge and Skills:

  • Familiar with FDA/MDR/ISO
  • Familiar with quality strategies and programs
  • Analytical
  • Process oriented
  • Detail Oriented Training and education

Experience: 

Combination of education and 1 year of experience in manufacturing and operations preferred

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USA - Nashville

300 Duke Drive
TN 37090 Nashville Directions

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