ECI
Senior Quality Engineer - Technical Transfer - Medical Devices #0570 Charlotte,
ECI, Charlotte, North Carolina, United States, 28245
Senior Quality Engineer - Technical Transfer - Medical Devices #0570 (Charlotte, NC)
ECI is a global leader of professional consulting services for the life sciences industry. Our mission is to provide transformative solutions with distinctive, sustainable, and long‑term value to clients in the life sciences sector. Role Overview
The Senior Quality Engineer will support cross‑functional teams in transferring equipment used in the production of medical devices to consolidate manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and business objectives. The role requires up to 50% travel on an as‑needed basis. Responsibilities
Support process validation, equipment qualification, and documentation transfer Provide product technical guidance on equipment validation strategies Drive continuous improvement in transfer processes to ensure timely completion of deliverables and maintain product quality Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards Provide support for testing, analysis, and continuous improvement Support updates to client processes or other documentation as directed Drive completion of quality activities within prescribed timelines Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field 8+ years of experience in medical device manufacturing, product development, or technology transfer Proven track record supporting complex, multi‑site projects Strong knowledge of design control, process validation, and manufacturing scale‑up Results‑oriented, positive attitude focused on delivering timely, accurate, and best‑in‑class execution Exceptional communication, collaboration, and problem‑solving skills Equal Opportunity Statement
ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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ECI is a global leader of professional consulting services for the life sciences industry. Our mission is to provide transformative solutions with distinctive, sustainable, and long‑term value to clients in the life sciences sector. Role Overview
The Senior Quality Engineer will support cross‑functional teams in transferring equipment used in the production of medical devices to consolidate manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and business objectives. The role requires up to 50% travel on an as‑needed basis. Responsibilities
Support process validation, equipment qualification, and documentation transfer Provide product technical guidance on equipment validation strategies Drive continuous improvement in transfer processes to ensure timely completion of deliverables and maintain product quality Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards Provide support for testing, analysis, and continuous improvement Support updates to client processes or other documentation as directed Drive completion of quality activities within prescribed timelines Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field 8+ years of experience in medical device manufacturing, product development, or technology transfer Proven track record supporting complex, multi‑site projects Strong knowledge of design control, process validation, and manufacturing scale‑up Results‑oriented, positive attitude focused on delivering timely, accurate, and best‑in‑class execution Exceptional communication, collaboration, and problem‑solving skills Equal Opportunity Statement
ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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