Quality Engineer

LivaNova•Houston, TX

1d•$80,000 - $100,000

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. 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.

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.

Responsibilities

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.