Quality Assurance Specialist

3 days ago


Mansfield, Ohio, United States Integra LifeSciences Full time
Transforming Healthcare through Quality Excellence

At Integra LifeSciences, we're committed to creating a better future for patients and healthcare professionals alike. As a Quality Assurance Specialist, you'll play a vital role in shaping the future of healthcare by driving quality improvement initiatives that make a meaningful impact.

Key Responsibilities:
  • Support quality improvement initiatives, including process and product characterizations, to drive continuous cost improvements.
  • Conduct benchmarking to develop more effective methods for improving quality and reducing risk.
  • Approve IQ, OQ, PQ, TMV, or software validation to ensure compliance with regulatory standards.
  • Develop and implement process monitoring and control methods to ensure product quality and safety.
  • Analyze and interpret data to inform process improvements and drive business outcomes.
Requirements:
  • Bachelor's degree or equivalent with 8+ years of experience, Master's degree with 5+ years of experience, or Doctoral degree with 3+ years of experience.
  • Relevant experience working in manufacturing/operations and in-depth knowledge of product/process risk management (FDA and ISO standards).
  • Experience with implementing risk mitigation strategies and good technical understanding of manufacturing equipment and processes.

Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.



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