Customer Quality Engineer

Join us today and make a difference in people's lives!
 

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.  The company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .”  LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.
 

LivaNova Neuromodulation:

As pioneers of the VNS (Vagus Nerve Stimulation) Therapy® system, LivaNova continues to advance medical device solutions for patients affected by Drug-Resistant Epilepsy (DRE) and Difficult-to-Treat Depression (DTD).  There are 3 million people in the U.S. alone and one on three people with epilepsy are drug resistant.  People with severe seizures have, on average, a shorter life expectancy and an increased risk of cognitive impairment particularly if the seizures developed in early childhood.  VNS Therapy for DRE is delivered through a device that sends mild pulses to the vagus nerve at regular intervals throughout the day in an effort to prevent seizures.

NM Customer Quality supports commercially available products like VNS Therapy as well as several devices currently undergoing clinical trials.

The NM Customer Quality team is responsible for technical support, complaint investigation and vigilance reporting to government authorities.

As a Customer Quality Engineer, you will provide real-time clinical and technical support for our customers across the globe. While investigating complaints you will communicate with customers, document your investigational findings and determine a root cause based on the investigation. Throughout these investigations, you will assess the reportability of the complaint in accordance with domestic and global regulations and submit required regulatory reports to government agencies. We expect this role to be fully trained on the complaint life cycle (complaint intake, investigation, root cause identification, and vigilance reporting). However, each Customer Quality Engineer has a focus area in either front end Technical Support or back end Complaint Investigation. 

On a daily basis Customer Quality Engineers:

• Provide real-time clinical and technical support to our customers through the Technical Support Call Center,

• Utilize product knowledge to educate customers while solving problems that impact patient care

• Support complaint investigation for both commercial patients as well as patients participating in clinical studies

• Evaluate priority level of reported complaints and manage them accordingly to ensure patient safety and customer satisfaction,

• Develop an investigation plan and perform the technical and clinical analyses needed for the complaint investigation,

• Drive and coordinate the investigations in close collaboration with LivaNova field representatives,

• Manage priorities to ensure timely investigation and closure of complaints,

• Develop a clear understanding of malfunction and adverse event reporting requirements and processes to submit reports to domestic and international governmental agencies,

• Collaborate with interdepartmental teams on department and interdepartmental projects,

• Update procedures and identify/implement process changes, as necessary.

Minimum Qualifications

• BS Degree in biomedical, electrical, life science, or another engineering discipline

Knowledge and Skills

• Regulated industry expertise and experience in a technical environment in the healthcare, medical device, or pharmaceutical fields a plus! 

• Superb time management skills

• Excellent problem solving and analytical skills

• Strong organizational skills. Ability to manage priorities

• Professional verbal and written communication skills

• Exceptional documentation skills

• Strong interpersonal skills. Ability to interface with technical resources and cross-functional teams. Setting a professional tone and establishing a cooperative partnership

• Thriving in a challenging, fast-paced, results-oriented environment