Senior Specialist, Continuous Improvement – SaMD

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🔥 1 minute ago

🎸 Mississippi – Remote

🎸 Mississippi – Remote

💵 $102.6k - $153.8k / year

⏰ Full Time

🟠 Senior

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Merative

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2022

⚕️ Healthcare Insurance

☁️ SaaS

🤖 Artificial Intelligence

Healthcare Insurance • SaaS • Artificial Intelligence

Merative is a healthcare data, technology, and analytics company. It offers a range of solutions aimed at improving health outcomes by focusing on clinical decision support, healthcare analytics, medical imaging, clinical development, and health and human services. Key products and services include Micromedex for clinical decision support, Zelta for clinical data management, Merge for imaging solutions, and Truven for healthcare analytics. Merative serves a diverse client base, including healthcare providers, life sciences companies, governments, health plans, and employers. The company is dedicated to enhancing healthcare delivery and decision-making by leveraging real-world data and advanced analytics to provide actionable insights and tailored solutions.

📋 Description

• Collaborate with stakeholders to assess workflows, identify improvement opportunities, and implement changes that enhance quality, efficiency, and consistency. • Partner with process owners to standardize and optimize QMS processes in alignment with regulations, standards, and best practices. • Lead cross-functional continuous improvement initiatives to strengthen key processes. • Design and deliver targeted programs to build problem-solving capability and promote adoption of best practices. • Implement tools and technologies that support efficient process execution. • Leverage data and input from teams (Program Management, R&D, Customer Success, Production, Regulatory Affairs, Quality, and Risk Management) to identify trends, prioritize opportunities, and drive improvements. • Establish KPI frameworks, visual management systems, and accountability mechanisms to enhance operational performance. • Communicate portfolio status, risks, and business impact clearly to stakeholders at all levels. • Support development and execution of corrective and preventive actions to address process gaps and recurring issues. • Facilitate root cause analysis and ensure effective follow-through to improve long-term performance. • Support internal and external audits, including inspection readiness activities, as needed. • Provide training and coaching to strengthen continuous improvement capabilities and reinforce standardized ways of working. • Act as a subject matter expert on process design, standardization, and continuous improvement within the QMS environment.

🎯 Requirements

• Bachelor’s degree in Engineering, Science, Quality Management, or a related field, or equivalent experience • Minimum of 8 years of experience in continuous improvement, operational excellence, or quality systems within healthcare technology, medical device, or life sciences industries. • Experience leading cross-functional initiatives and applying improvement tools to deliver measurable results. • Working knowledge of standards such as ISO 13485 and ISO 14971. • Familiarity with regulatory requirements including 21 CFR Part 820, SOR/98-282, and EU MDR (2017/745). • Understanding of Software as a Medical Device (SaMD) and software development lifecycles. • Experience with process mapping and workflow tools (e.g., Microsoft Visio). • Hands-on experience with Lean / Six Sigma methodologies and tools such as 5S, value stream mapping, kaizen, Pareto analysis, and root cause analysis (e.g., 5 Whys, fishbone).

🏖️ Benefits

• Remote first / work from home culture • Flexible vacation to help you rest, recharge, and connect with loved ones • Paid leave benefits • Health, dental, and vision insurance • 401k retirement savings plan • Infertility benefits • Tuition reimbursement, life insurance, EAP – and more!