Quality Engineer

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.

The Quality Engineer will be working in a cross-functional environment, with a multi-disciplinary team of engineers within the Quality Engineering Department. You will have a demonstrable impact on the patient experience by ensuring that the devices we design, develop, and manufacture are safe and effective.

Job Duties

• Reviews product and QMS changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts.

• Acts as business process owner of the nonconformance report (NCR) management system, including material review board (MRB) activities, monitoring the timeliness and effectiveness of the system and activities.

• Identifies which complaints and trends warrant investigation via the CAPA process and initiates CAPA investigations as required.

• Identifies and initiates product and labeling improvements based on complaint and trending data.

• Lead (technical expert) and oversee/approve investigations of manufacturing nonconformities, audit nonconformities and CAPAs to identify root cause and corrective actions in a timely and compliant manner.

• Monitors the effectiveness of corrective actions.

• Collaborates with Operations to define and implement systems that enhance efficiency, productivity and quality.

• Provides quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for validation activities.

• Ensures that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes and global QMS processes.

• Performs internal audits as assigned per the internal audit schedule.

• Compiles and presents quality data in management review.

• Generates, maintains and updates risk management documentation throughout the life cycle of a product.

• Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert.

Minimum Requirements

• Bachelor of Science in Engineering

• 3+ years of engineering experience in a medical or biotechnology industry involved in supporting electrical engineering activities such as those previously detailed above for electronic medical devices.

• Required knowledge includes electrical design, statistics, and medical device regulations including the QMS processes required to develop and manufacture medical devices.

Travel Requirements

• This position may require occasional business travel of 10% or more of the time.

Pay Transparency

• A reasonable estimate of the annual base salary for this position is $80,000 - $100,000 + discretionary annual bonus. Pay ranges may vary by location and will be awarded based on experience.

Employee benefits include:

• Health benefits - Medical, Dental, Vision

• Personal and Vacation Time

• Retirement & Savings Plan (401K)

• Employee Stock Purchase Plan

• Training & Education Assistance

• Bonus Referral Program

• Service Awards

• Employee Recognition Program

• Flexible Work Schedules