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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Operations Quality Manager

Job Summary

The Operations Quality Manager, under the general direction of the Site Head of Quality is responsible for providing quality support to the Operations departments, and other support departments as needed.  As this is a diverse position, having a major impact on the company's ability to market products in accordance with US and international regulations, the responsibilities for this position may include all, or focus on only a few of the responsibilities listed below, depending on the needs of the business:

Position Responsibilities

  1. Manage quality support for operations including device history record and batch release processes.
  2. Drive measurable quality improvements in support of operations.
  3. Manages quality, compliance, and timely closure of complaints through manufacturing investigations. Supervises Quality Engineers and Specialists that process complaints about the site. Oversees, coordinates, and participates in elements of investigations regarding customer complaints.
  4. Provide failure analysis of product, components, and or systems for identification of root cause and corrective and preventive actions.
  5. Conduct internal Quality System audits to assure compliance with domestic and international regulations and requirements.
  6. Develop, implement, and or review procedures and work instruction to ensure compliance to regulatory and or quality requirements.  
  7. Perform review of Technical Files, Device History Files, and design changes.
  8. Seek out and apply best quality assurance methods and practices in support of Quality objectives.
  9. Performs trending of Quality data to proactively identify opportunities for System improvements.
  10. Develops, reviews, and approves engineering change orders for compliance.
  11. Perform Process Validation (IQ, OQ & PQ) for new product transition from engineering to manufacturing and production, including test system qualification.
  12. Review qualification, verification and validation studies in support of product and process changes.
  13. Participate in MRB activity to assure timely resolution of material non-conformance and corrective action.
  14. Provide supervision and guidance to Quality Technicians and Inspectors.  
  15. Performs special assignments as assigned by the Quality Manager.

Position Requirements

  1. Requires a Bachelors degree in a technical field.  Masters preferred.
  2. Knowledge of FDA, EU MDR and ISO procedures and requirements.
  3. Strong leadership and team-building skills.
  4. Strong written and verbal communication skills.
  5. Knowledge and experience with Sterilization validation and process management preferred.
  6. ASQ Certification as a Quality Engineer and/or Reliability Engineer.