Customer Quality Engineer I
About The Position
As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives. 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).
Requirements
- BS Degree in biomedical, electrical, life science, or another engineering discipline
- Knowledge and Skills
- 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
Nice To Haves
- Regulated industry expertise and experience in a technical environment in the healthcare, medical device, or pharmaceutical fields a plus!
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
