Senior Engineer, Risk Management

Job not on LinkedIn

🔥 0 minutes ago

🌽 Illinois – Remote

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💵 $92k - $138k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

👻 Ghost score 0%

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Logo of Medline Industries, LP

Medline Industries, LP

10,000+ employees

Founded 1910

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 Private Equity Round on 2021-06

Healthcare • Logistics • Manufacturing

Medline Industries, LP is a leading healthcare company that focuses on improving clinical, financial, and operational outcomes for its customers. The company offers a wide array of over 335,000 medical products and boasts extensive warehousing capabilities with more than 28 million square feet of space. With a significant global presence of 43,000 employees, Medline provides agile and scalable solutions across all points of care, achieving a 95% next-day delivery rate within the US. The company's mission is to enhance healthcare delivery by providing superior products, supply chain resilience, and clinical expertise, all while fostering strong customer relationships through tailored, problem-solving solutions.

📋 Description

• Create and align global risk management processes • Evaluate risks and approve Change Controls, FMEA, Medical Device Reporting, Recalls, Health Hazard Evaluations, and other major quality events • Communicate risks to senior global management • Build relationships with quality and business partners • Lead global cross-department collaboration with R&D, Manufacturing, and other sites • Create and manage systems to analyze quality and risk management data • Work with Subject Matter Experts to create risk-based dashboards for real-time decision-making and management reporting • Advise stakeholders on implementing risk controls and create and implement controls • Identify and address inefficiencies in the global quality management system • Lead projects and ensure deadlines and goals are met • Update management and teams on progress • Identify project-delaying issues and recommend timeline improvements

🎯 Requirements

• Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree • At least 4 years of QA/QE experience in a cGMP Device or environment • At least 2 years of direct risk management experience related to FDA regulated products • Experience creating quality sub-systems and leading complex projects • Ability to manage 5+ projects at a time • Ability to manage multiple priorities • Self-starter attitude • Good oral and writing skills • Ability to work independently and as a team • Working understanding of FDA, GMP, ISO 13485, and ISO 14971 • Experience facilitating FMEAs • Systems or clinical engineering experience • Master's degree in a related field preferred • At least 5 years of QA/QE experience preferred • Six Sigma certification preferred

🏖️ Benefits

• Competitive total rewards package • Continuing education & training • Bonus and/or incentive eligibility • Health insurance • Life and disability insurance • 401(k) contributions • Paid time off • Employee Assistance Program • Employee Resource Groups • Employee Service Corp • Career growth opportunities

Apply Now

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