Senior CAPA Engineer

🕒 September 17

🐊 Florida, New York, +3 more states – Remote

🐊 Florida – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote ⚓ Rhode Island – Remote

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 22%

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Fresenius Medical Care

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1996

💼 Consulting

📦 Logistics

🏭 Manufacturing

💰 $6.1M Post-IPO Equity on 2020-02

Consulting • Logistics • Manufacturing

Fresenius Medical Care is a global health care company specializing in providing products and services for individuals with renal diseases. Founded in 1996, Fresenius Medical Care is the leading provider of dialysis treatment, building on the expertise of its parent company, the Fresenius health care group. The company is dedicated to improving the quality of life for patients worldwide by delivering high-quality care and innovative renal therapies. With a global presence, Fresenius Medical Care operates over 4,000 dialysis clinics and employs more than 125,000 people. The company's core values include collaboration, proactivity, reliability, and excellence, fostering a diverse and inclusive work environment to support its mission in delivering superior patient care.

📋 Description

• Lead harmonization and standardization of the product transfer process • Execute and oversee product transfer processes for assigned regional/global areas • Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer • Ensure product quality at receiving manufacturing sites during product transfer projects • Partner with CE vertical quality, R&D, plant quality, and manufacturing teams on new-product and site-to-site transfers • Ensure transfer projects meet quality and regulatory requirements, including quality planning, site registration, PFMEA, training, inspection plans, and validation plans • Transfer reliable quality products into manufacturing through partnership with value streams and manufacturing operations • Establish receiving-site quality metrics for successful product transfers • Oversee and execute policies and procedures for consistent outcomes • Develop and execute quality and validation plans • Deliver procedural updates associated with adding new products at receiving manufacturing facilities • Ensure transfer activities comply with the quality system, FDA QSRs, and ISO 13485 • Perform other related duties as assigned

🎯 Requirements

• Bachelor’s Degree required • 6–8 years of relevant experience in Quality, Manufacturing and/or Engineering discipline • Experience in medical device, pharma or another regulated industry • Engineering background • Direct experience in design and/or manufacturing of medical devices/pharma in a GMP environment • Proven track record in cross-functional collaboration • Knowledge of FDA, MDD/MDR regulation in medical device and pharma • Excellent communication skills with the ability to present and explain complex topics to multiple levels within the organization • Demonstrated practice of continuous improvement and designing efficiency into processes • Approximately 30% travel required • Bilingual in Spanish — nice to have • Automotive PPAP experience is a plus • Advanced Degree desirable

🏖️ Benefits

• Medical, dental, and vision insurance • 401(k) with company match • Paid time off • Parental leave • Potential for performance-based bonuses depending on company and individual performance • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions