Sr Quality Engineer

Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes.

About This Role:

Veranex has an exciting opportunity to join our team as a Quality Engineer II or Senior Quality Engineer. You will be part of a team working to improve lives globally through medical technology innovation. The Quality Engineer II or Senior Quality Engineer organizes and coordinates the quality activities for clients to help identify and meet quality engineering and quality management system (QMS) needs. Evaluates design inputs, outputs and design changes for quality requirements, risk management and impact assessment. Collaborates with clients to assure quality, risk, or other management plans for design, production and maintenance processes for general and specific product performance needs are established according to the client's AMS while ensuring these activities are in accordance with industry standards and regulations. Focus is product lifecycle; design control, design transfer, production, and change management and processes for general and specific product performance needs.

Quality Engineer II

What You Will Do:

• Leads the administration of device design and change management and performs quality engineering activities with clients to assure quality controls and design changes meet requirements
• Conducts process risk management for novel and existing medical devices (PFMEA)
• Develops, documents, and validates inspection and test methods to support design control Process Validation, in-process inspection, and final inspection activities.
• Provides input and/or oversight for quality system related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes.
• Participates in continuous improvement efforts related to quality engineering processes.

Required skills:

• Bachelor's degree in software engineering or life sciences
• 2-4 years of relevant experience in medical devices
• Strong knowledge of medical device regulations and standards

• Strong knowledge of medical device regulations, guidance documents and standards (i.e., quality system regulations (QSR) International Organization for Standardization (ISO) 13485, ISO 14971, ISO 62304, related ASTM, ANSI, AAMI, TIR standards and guidance documents as needed)
• Strong knowledge of off-the-shelf (OTS) software and software of unknown provenance (SOUP) requirements, cybersecurity design, testing and maintenance process.
• Strong understanding of full product lifecycle for a medical device and an understanding of the differences between product lifecycles for traditional programmable electrical medical systems (PEMS) devices vs. software as a medical devices (SaMD)

• Strong understanding of automated testing frameworks

• Advanced computer science fundamentals including data structures, programming experience and an understanding of fundamental algorithms

Senior Quality Engineer

What You Will Do:

• Leads the administration of device design and change management and performs quality engineering activities with clients to assure quality controls and design changes meet requirements
• Conducts process risk management for novel and existing medical devices (PFMEA)
• Develops, documents, and validates inspection and test methods to support design control Process Validation, in-process inspection, and final inspection activities.
• Provides input and/or oversight for quality system related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes.
• Participates in continuous improvement efforts related to quality engineering processes
• Trains and mentors new and less experienced engineers
• Participates in continuous improvement efforts related to quality engineering processes.
• May support business development by participating in potential client meetings, educating clients, and providing proposal input.

Required skills:

• Bachelor's degree in software engineering or life sciences
• 4-6 years of relevant experience in medical devices
• Experience mentoring/training other engineers
• Strong knowledge of medical device regulations and standards

• Strong knowledge of medical device regulations, guidance documents and standards (i.e., quality system regulations (QSR) International Organization for Standardization (ISO) 13485, ISO 14971, ISO 62304, related ASTM, ANSI, AAMI, TIR standards and guidance documents as needed)
• Strong understanding of full product lifecycle for a medical device and an understanding of the differences between product lifecycles for traditional programmable electrical medical systems (PEMS) devices vs. software as a medical devices (SaMD)
• Strong understanding of automated testing frameworks
• Advanced computer science fundamentals including data structures, programming experience and an understanding of fundamental algorithms

Preferred:

• Demonstrated experience with client management
• Experience with different quality management systems
• Provides risk management expertise in the evaluation and design of product, design validation and verification

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.