Sr Manager, Design Quality Assurance - Continuous Improvement

• Drive and implement continuous improvement initiatives to optimize product development processes in partnership with cross-functional process owners.  

• Evaluate and optimize processes to ensure compliance with FDA, ISO 13485, ISO 14971, IEC 62304, and other regulatory standards. 

• Collaborate with internal standards teams to interpret and implement evolving industry and regulatory standards. 

• Partner with enterprise and cross-functional teams (R&D, Systems, Regulatory, Quality, Manufacturing, IT) to help drive systems/tools improvement initiatives and help resolve process inefficiencies. 

• Develop and track key performance indicators (KPIs) to measure the impact and sustainability of improvement initiatives. 

• Lead change management and training efforts to embed a culture of continuous improvement across the organization. 

• Support audit and inspection readiness by ensuring robust documentation and traceability of process improvements. 

• Lead and/or provide robust support for CAPAs as quality partners, ensuring timely investigations, root cause analysis, and effective implementation of corrective actions. 

• Benchmark internal processes against industry best practices and recommend enhancements.  

• Champion digital transformation opportunities within design quality systems. 

• Introduce and implement the best practices for the Software Development Life Cycle (SDLC), including requirements management, design verification, software risk management, and configuration control. 

• Collaborate with software engineering and quality teams to ensure alignment with IEC 62304 and other relevant software standards. 

• Drive initiatives that reduce development cycle times and improve execution efficiency without compromising quality or compliance. 

• Promote a proactive quality culture that supports innovation and accelerates time to market for new products. 

Education and Experience: 

• Bachelor’s degree in engineering, Life Sciences, or related field (master’s preferred) 

• 8+ years of experience in the medical device industry, with strong knowledge of design controls and quality systems. 

• Proven track record in leading cross-functional continuous improvement projects. 

• Deep understanding of regulatory standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, etc.). 

• Experience implementing SDLC best practices in regulated environments. 

• Lean Six Sigma certification (Green Belt or higher) preferred. 

• Excellent communication, leadership, program management and stakeholder management skills. 

Skills/Competencies:  

• Effective verbal and written communication skills. 

• Experience collaborating and communicating with individuals at multiple levels in an        organization. 

• Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.  

• Conflict resolution skills including persuasive management techniques required. 

• Strong analytical and problem-solving skills. 

• Able to work effectively in a high-stress, high-energy environment. 

• Ability to influence people and projects in a fast-moving environment.