Sr Specialist, Continuous Improvement- SaMD

• 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.

Core Competencies:

• Strong problem-solving skills with a focus on practical, results-oriented solutions.

• Solid organizational and project management abilities, with capacity to manage multiple priorities.

• Effective communication and facilitation skills to present data and recommendations clearly.

• Proven ability to influence and drive change across teams without direct authority.

Technical Skills (Preferred):

• 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).

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.

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