The Role
Senior Engineer supporting manufacturing processes and products through process improvement, validation, product transfers, change controls, new product introductions, and capital projects. The role analyzes and resolves manufacturing issues, coordinates equipment and process validations, prepares regulatory documentation, supports FDA interactions, and provides technical assistance to manufacturing teams. It also requires statistical analysis, cross-functional coordination, supplier interaction, and bilingual Spanish-English communication.
Summary Generated by Built In
We are seeking an experienced Principal Engineer to provide technical and organizational leadership for Process & Product Technical Services within the Medical Devices business unit. This role is responsible for leading strategic engineering projects, supporting manufacturing operations, driving process and product improvements, and developing engineering talent. The position oversees a team consisting of a Senior Engineer and an Engineer II while collaborating across multiple functions to ensure regulatory compliance, operational excellence, and successful delivery of business objectives.
Requirements
- BS in Engineering or Science Field and 3-5 years related experience in manufacturing or project engineer in a closely related industry or
MS in Engineering and 1-2 years related experience in manufacturing or project engineer in a closely related industry. - Bilingual (Spanish and English) written and verbal.
Skills Required
- Bachelor’s degree in Engineering or a Science field
- 3–5 years of related experience in manufacturing or project engineering in a closely related industry
- Alternatively, a Master’s degree in Engineering with 1–2 years of related manufacturing or project engineering experience
- Bilingual written and verbal communication in Spanish and English
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
