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.

As a global leader in neuromodulation, our advanced solutions have made significant contributions to the world of neurology. We strive to advance patient care through the insightful application of innovative technologies.

The Quality Engineer is responsible for supporting electrical medical devices through their full life-cycle.  This includes design assurance activities as part of new product development and process/product changes and leading investigations for technically complex and challenging manufacturing nonconformities or post-market failures to identify root cause/corrective actions in a timely and compliant manner. This specific Quality Engineer position will primarily focus on electrical medical devices including implantable pulse generators and programmers.  

The Quality Engineer’s role on new product development teams includes investigating anomalies identified during the development process, providing value-added feedback in technical design reviews, leading risk management activities, ensuring that we are applying the right engineering approaches and methods that meet procedural and regulatory requirements for all phases of development projects including design inputs, design transfer (process validation), design verification and validation, etc. 

This person 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. This person will interact on a daily basis with Manufacturing Engineering, R&D Engineering and Project Management, reporting directly to the Sr. Director of Quality Engineering. 

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 Transparenc