Sr Manager, Design Quality Assurance - Continuous Improvement

Sr. Manager, Design Quality Assurance Continuous Improvement

The Sr. Manager, Design Quality Assurance Continuous Improvement, is responsible for leading strategic and results-driven Continuous Improvement initiatives that enhance efficiency, compliance, and innovation across our medical device design and development processes. This role will focus on driving process improvements while aligning with industry standards and collaborating with enterprise and cross-functional teams to optimize quality systems and product development workflows. In addition, focus on integrating best practices for the Software Development Life Cycle (SDLC) and accelerating efficient execution to enable faster time to market while maintaining compliance with global regulatory standards.

If you're a quality-focused leader with a passion for continuous improvement and cross-functional collaboration with medical industry experience, this opportunity is for you to drive innovative, efficient, and compliant processes.

Responsibilities:

• 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.