Veranex
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Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.
About This Role
Veranex has an exciting opportunity to join our team as a Senior Quality Engineer. You will be part of a team working to improve lives globally through medical technology innovation. The 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. 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 May support business development by participating in potential client meetings, educating clients, and providing proposal input Required skills
Bachelor’s degree in engineering or life sciences, or an equivalent combination of education, training, and experience 4-6 years of relevant experience in medical devices Experience mentoring/training other engineers Strong knowledge of medical device regulations, guidance documents and standards (QSR, 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 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.
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Veranex has an exciting opportunity to join our team as a Senior Quality Engineer. You will be part of a team working to improve lives globally through medical technology innovation. The 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. 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 May support business development by participating in potential client meetings, educating clients, and providing proposal input Required skills
Bachelor’s degree in engineering or life sciences, or an equivalent combination of education, training, and experience 4-6 years of relevant experience in medical devices Experience mentoring/training other engineers Strong knowledge of medical device regulations, guidance documents and standards (QSR, 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 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.
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