Senior CAPA Engineer

This is a fully remote position, open to applicants in Florida, +4 more states.

📋 Description

• Lead the alignment and standardization of the product transfer process.

• Execute and manage product transfer processes for designated regional and global areas.

• Develop, implement, and sustain Global Product Transfer processes for design and manufacturing product transitions.

• Ensure product quality at receiving manufacturing sites during product transfer initiatives.

• Collaborate with CE vertical quality, R&D, plant quality, and manufacturing teams on new product and site-to-site transfers.

• Ensure that transfer projects adhere to quality and regulatory standards.

• Establish quality planning, site registration, receiving-site PFMEA, training requirements, inspection plans, and validation plans.

• Facilitate the transfer of reliable quality products into manufacturing through collaboration with vertical value streams and manufacturing operations.

• Assist in the establishment of quality metrics at receiving sites.

• Oversee and implement policies and procedures to guarantee consistent outcomes.

• Develop and execute quality and validation plans.

• Provide procedural updates related to the addition of new products at receiving manufacturing facilities.

• Ensure that transfer activities comply with the quality system, FDA QSRs, and ISO 13485.

• Perform other related duties as assigned.

⛳️ Requirements

• Bachelor’s Degree.

• 6–8 years of relevant experience in Quality, Manufacturing, and/or Engineering disciplines.

• Experience in the medical device, pharmaceutical, or other regulated industries.

• Background in Engineering.

• Direct experience in the design and/or manufacturing of medical devices or pharmaceuticals in a GMP environment.

• Knowledge of FDA, MDD/MDR regulations in medical devices and pharmaceuticals.

• Proven track record in cross-functional collaboration.

• Excellent communication skills with the capability to present and clarify complex topics at multiple organizational levels.

• Demonstrated practice of continuous improvement and process efficiency design.

• Bilingual in Spanish — a plus.

• Approximately 30% travel required.

🏝️ Benefits

• Medical, dental, and vision insurance.

• 401(k) with company match.

• Paid time off.

• Parental leave.

• Potential for performance-based bonuses based on company and individual performance.