Senior Quality Engineer- Technical Transfer -Medical Devices
Listed on 2025-12-06
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Engineering
Quality Engineering, Biomedical Engineer
Senior Quality Engineer - Technical Transfer - Medical Devices #0572 – Taunton, MA
Join to apply for the Senior Quality Engineer - Technical Transfer - Medical Devices #0572 role at ECI
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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. You will work in fast‑paced, cross‑functional teams to maintain and support quality‑engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. This role requires up to 50% travel on an as‑needed basis.
WhatYou’ll Do
- 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.
- Confirm that products and processes meet specific standards.
- Support testing, analysis, and continuous improvement initiatives.
- Update client processes or other documentation as directed.
- Drive completion of quality activities within prescribed timelines.
- 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.
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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