Director of Quality Assurance

4 weeks ago


Limerick PA, United States Globus Medical Full time

At Globus Medical, we strive to deliver innovative solutions that improve the quality of life for patients with musculoskeletal disorders.

Our team is driven by a passion to transform clinical insights into tangible musculoskeletal solutions, and we're committed to ensuring the highest level of manufacturing quality for our medical devices.

As a key member of our team, you will be responsible for leading our quality assurance efforts, ensuring compliance with regulatory requirements, and implementing quality improvement initiatives based on Lean Management and Six Sigma principles.

Key responsibilities include:

  • Providing leadership for business process excellence and fostering a culture of compliance and excellence.
  • Ensuring the integration of risk management and risk analysis based on ISO 14971.
  • Developing, implementing, and maintaining quality planning supporting ISO 13485 quality system requirements.
  • Overseeing all quality functions, including documentation and training, customer feedback, nonconformance, CAPAs, supplier quality management, QC inspection, and final product release.
  • Managing and maintaining the Company's internal quality audit program and assessing improvement initiatives resulting from all quality audits.

Requirements include:

  • A bachelor's degree in Engineering, Science, or Business, with a relevant post-graduate degree or qualification being an advantage.
  • Minimum of 5 years of experience leading quality assurance/quality systems, with experience in FDA and CE Notified Body inspections.
  • At least 10 years of progressive experience in QA/QC management in a manufacturing environment, preferably in the medical device industry.
  • Lean and Six Sigma experience, with a proven track record of business performance improvement and personnel development.

We are an equal opportunity employer and value diversity and inclusion in the workplace. If you are a motivated and experienced professional looking to make a difference in the lives of patients, we encourage you to apply for this exciting opportunity.



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