Quality Engineer 2

Veranex, Inc. • Providence, RI

20h • Onsite

About The Position

Veranex, an Innovation CRO focused on MedTech, aims to improve patient outcomes by accelerating client innovations to market. The Quality Engineer 2 will join a team dedicated to medical technology innovation, organizing and coordinating quality activities for clients to identify and meet quality engineering and quality management system (QMS) needs. This role involves evaluating design inputs, outputs, and design changes for quality requirements, risk management, and impact assessment. The engineer will collaborate with clients to establish quality, risk, or other management plans for design, production, and maintenance processes, ensuring these activities align with the client’s AMS, industry standards, and regulations. The primary focus is on the product lifecycle, including design control, design transfer, production, and change management for general and specific product performance needs.

Requirements

• Bachelor’s degree in engineering or life sciences, or an equivalent combination of education, training, and experience
• 2-4 years of relevant experience in medical devices
• Experience mentoring/training other engineers
• 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 life cycle, including definition of customer needs, development, design testing, design transfer, manufacturing scale up, distribution, service, and post market analysis
• Strong understanding of concepts and principles of Quality Assurance with respect to new product development, regulatory bodies, external suppliers, product manufacturing and product servicing
• Excellent written and verbal communication skills
• Excellent attention to detail

Nice To Haves

• 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

Responsibilities

• 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.
• May support business development by participating in potential client meetings, educating clients, and providing proposal input.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees