Senior CAPA Engineer

🔥 0 minutes ago

🐊 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 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 comply with quality and regulatory requirements • Define quality planning, site registration, receiving-site PFMEA, training requirements, inspection plans, and validation plans • Transfer reliable quality products into manufacturing through partnership with vertical value streams and manufacturing operations • Assist in establishing receiving-site quality metrics • Oversee and execute policies and procedures to ensure 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 • 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 • Knowledge of FDA, MDD/MDR regulation in medical device and pharma • Proven track record in cross-functional collaboration • 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 • Bilingual in Spanish — nice to have • Approximately 30% travel

🏖️ 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