Sr Specialist, Continuous Improvement- SaMD

Responsibilities

• 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.

Qualifications

• Education: Bachelor’s degree in Engineering, Science, Quality Management, or a related field, or equivalent experience.
• Certification or training in Lean, Six Sigma, or continuous improvement methodologies is an asset.
• 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.