Senior Specialist, Continuous Improvement – SaMD

This is a fully remote position, open to applicants in Mississippi.

📋 Description

• Collaborate with stakeholders to evaluate workflows, recognize opportunities for enhancement, and implement modifications that improve quality, efficiency, and consistency.

• Work alongside process owners to standardize and optimize Quality Management System (QMS) processes in accordance with regulations, standards, and best practices.

• Lead cross-functional initiatives for continuous improvement to bolster key processes.

• Develop and deliver focused programs to enhance problem-solving skills and encourage the adoption of best practices.

• Implement tools and technologies that facilitate efficient process execution.

• Utilize data and feedback from teams (Program Management, R&D, Customer Success, Production, Regulatory Affairs, Quality, and Risk Management) to identify trends, prioritize opportunities, and drive enhancements.

• Create KPI frameworks, visual management systems, and accountability structures to improve operational performance.

• Clearly communicate portfolio status, risks, and business impact to stakeholders at all levels.

• Assist in the development and execution of corrective and preventive actions to rectify process gaps and recurring issues.

• Facilitate root cause analysis and ensure effective follow-up to enhance long-term performance.

• Support internal and external audits, including preparation for inspections, as necessary.

• Provide training and coaching to bolster continuous improvement capabilities and reinforce standardized working methods.

• Serve as a subject matter expert in 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.

• At least 8 years of experience in continuous improvement, operational excellence, or quality systems within healthcare technology, medical device, or life sciences sectors.

• Proven experience leading cross-functional initiatives and utilizing improvement tools to achieve measurable outcomes.

• 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 the software development life cycle.

• Experience with process mapping and workflow tools (e.g., Microsoft Visio).

• Practical 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!