Sr Specialist, Continuous Improvement- SaMD

Merative•Mississauga, ON

7d•$102,564 - $153,846•Remote

About The Position

The Sr Specialist, Continuous Improvement (CI) leads cross-functional process improvement initiatives to enhance the efficiency, effectiveness, and maturity of key processes that support Merge Healthcare’s medical imaging solutions. This role partners with process owners and stakeholders to identify improvement opportunities, establish performance measures, standardize ways of working, and drive sustainable operational change within a regulated quality environment. The Sr Specialist, Continuous Improvement applies data-driven methods, continuous improvement tools, and strong facilitation skills to improve process performance and support quality and compliance objectives.

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.

Nice To Haves

Certification or training in Lean, Six Sigma, or continuous improvement methodologies is an asset.
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).

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.