Quality Engineer

LivaNova•Houston, TX

38d•Onsite

About The Position

This Job implements Neuromodulation Sustaining Quality Engineering functional activities. This may include, but not be limited to the following areas: Functional responsibilities of this position include: Reviews product and QMS changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts Ensures the quality of new digital processes, tools, and technologies as they are integrated across the business. This role will require an understanding of digital technologies to drive improvements in processes, automation, and data quality. Review and develop testing protocols and validation processes for digital tools, software, and systems being deployed. Support 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; Performs other duties as may be required by management. To ensure successful execution of the responsibilities outlined above, a successful contributor will: Develop and maintain strong, positive business relationships with key internal customers such as Operations, Manufacturing Engineering, R&D, Purchasing, Project Management Office (PMO), Clinical, Regulatory Affairs, Sales and Marketing, IT and Finance (as appropriate) to fulfill Quality assurance activities, support audits / inspections, and develop and implement quality plans that will ensure company compliance with regulatory requirements. Gain a full understanding and knowledge of how LivaNova devices are designed and manufactured, how they function, and how they deliver clinical benefit. Maintain and improve technical knowledge in area of expertise to provide value added feedback for new product development, investigations, and product/process changes to ensure the safety and effectiveness of LivaNova devices. Collaborate with other areas within Quality to achieve quality objectives. Travel Requirements This position may require occasional business travel of 10% or more of the time.

Requirements

A minimum of a BS in Engineering is required.
Appropriate written and verbal communication skills in English and in any other relevant language(s).
Understanding of basic quality engineering principles including, but not limited to: quality leadership, implementation, acceptance sampling, statistical process control, lean business systems and other continuous improvement techniques, and risk management.
Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders.
Good team player: open and honest when communicating among peers and management. Resolves most issues with peers, but understands what issues are important to escalate to management.
Strong interpersonal skills.
Familiarity with medical industry terminology.
Proficient in MS Office including Word, Power Point, and Excel.

Nice To Haves

A minimum of two (2) years of related experience in the medical device industry is preferred.
Preferred experience with digital transformation projects, including the integration of new technologies and tools.
Experience working in a regulated environment industry such as a FDA medical device manufacturer.
Technical education and experience in an area relevant to LivaNova devices.

Responsibilities

Reviews product and QMS changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts
Ensures the quality of new digital processes, tools, and technologies as they are integrated across the business.
Review and develop testing protocols and validation processes for digital tools, software, and systems being deployed.
Support 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
Performs other duties as may be required by management.
Develop and maintain strong, positive business relationships with key internal customers such as Operations, Manufacturing Engineering, R&D, Purchasing, Project Management Office (PMO), Clinical, Regulatory Affairs, Sales and Marketing, IT and Finance (as appropriate) to fulfill Quality assurance activities, support audits / inspections, and develop and implement quality plans that will ensure company compliance with regulatory requirements.
Gain a full understanding and knowledge of how LivaNova devices are designed and manufactured, how they function, and how they deliver clinical benefit.
Maintain and improve technical knowledge in area of expertise to provide value added feedback for new product development, investigations, and product/process changes to ensure the safety and effectiveness of LivaNova devices.
Collaborate with other areas within Quality to achieve quality objectives.