Senior Quality Manager
A great opportunity is available to join the Edwards Lifesciences team as a Senior Quality Manager. This position will manage the Quality Systems for Critical Care and Vascular business, including complaint handling, CAPA, and internal external audits.
Key responsibilities will include:
- Oversee risk management and post market surveillance activities.
- Interface with external parties during regulatory inspections.
- Oversee scheduling and execution of internal and external audits.
- Manage complaint systems and complaint processing to meet internal goals and compliance requirements.
- Partner with new product development teams to prior to clinical and commercial launch.
- Drive continuous improvements for quality systems.
- Manage and develop staff.
About Edwards
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 7,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we help ensure that patients regain and even improve their quality of life.
Edwards is credited with pioneering the practice of hemodynamic monitoring with the launch of the original Swan-Ganz™ catheter in the early 1970s. Today, Edwards' extensive line of hemodynamic monitoring catheters, sensors and bedside patient monitoring tools continue to be considered the gold standard in critical care medicine. Edwards has played a major role in evolving critical care monitoring technologies, selling more than 30 million catheters and monitors worldwide. The business unit has revenues of $450mil+ and has experienced double digit sales growth
The Senior Quality Manager position requires a minimum of five years experience in Quality Management, Quality Engineering and/or Regulatory Compliance, preferably in the medical device industry. Experience in Quality System auditing desired.
Additional qualifications include:
- Green or Black Belt certification desired.
- ASQ certification desired.
- Knowledge of FDA GMPs and ISO/EN standards desired.
- Good analytical skills and strong communication skills (verbal written).
- Excellent teamwork skills, creativity, high energy level, results orientation and project management skills are required.
A Bachelors Degree is required, preferably in a science or engineering field.
Additional Information:
- Travel Percentage: 10%
