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Quality Assurance Manager

1 month ago


Lincolnshire, Kentucky, United States Sysmex America Full time
Job Title: Quality Assurance Manager

At Sysmex America, we are seeking a highly skilled Quality Assurance Manager to oversee and manage the quality of product and process at our facility. The successful candidate will ensure that quality management systems processes are adhered to in accordance with established Good Manufacturing Practices (GMP), ISO, and applicable regulatory requirements.

The Quality Assurance Manager will be responsible for ensuring the accurate and timely completion of Quality Management System documents, including CAPAs, Non-Conformances, Deviations, and other processes measured in accordance with Quality Objectives and Key Performance Indicators.

The ideal candidate will have a Bachelor's degree in a related field and 5-8 years of experience in QA in a related industry. Knowledge of cGMP (FDA QSR) and ISO 13485 regulations is required. ASQ or other industry certifications are a plus.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality, we encourage you to apply for this exciting opportunity.

Key Responsibilities:

  • Oversee and manage the quality of product and process at Sysmex America
  • Ensure quality management systems processes are adhered to in accordance with established Good Manufacturing Practices (GMP), ISO, and applicable regulatory requirements
  • Ensure the accurate and timely completion of Quality Management System documents
  • Lead a team of Quality professionals responsible for monitoring day-to-day business activities
  • Support SRA quality management systems activities, including document control, internal/external/supplier/customer audits, complaint handling, and change management

Requirements:

  • Bachelor's degree in a related field
  • 5-8 years of experience in QA in a related industry
  • Knowledge of cGMP (FDA QSR) and ISO 13485 regulations
  • ASQ or other industry certifications are a plus

What We Offer:

  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • A dynamic and supportive work environment