Customer Quality Engineer

Remote in Houston, TX       ·       Full time

Full Job Description

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

We are looking for someone who is a self-starter, independent critical thinker with a high aptitude to work autonomously to make meaningful decisions. A career as a Customer Quality Engineer includes working at an innovative medical device company with Class III medical devices, where you will be able to develop and grow your skills and career within engineering.

As part of our team of 4500 employees worldwide, your unique skills and contributions will help more than 3000 hospitals/facilities provide the latest neuromodulation care in over 85 countries.

Our Houston office is a manufacturing site for the Neuromodulation (NM) therapeutic. This area includes the implantable VNS Therapy system which is used as adjunctive therapy in reducing the frequency of seizures in patients with refractory epilepsy and as a long-term adjunctive treatment of chronic or recurrent depression (http://www.vnstherapy.com).

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

Location

Neuromodulation Customer Quality is based in Houston, TX at our corporate offices however for the right candidates we offer the opportunity to work remotely anywhere in the United States.

For Colorado-based roles: Minimum annual salary of $60K. You may also be offered a bonus and health benefits.

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Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Background Checks at LivaNova:

Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Please click here to apply.