Senior Quality Engineer Manager Role
We are seeking a highly skilled Senior Quality Engineer Manager to champion healthcare access and equity for all.
This is a senior leadership role that requires a deep understanding of quality engineering principles and practices. The successful candidate will lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
The Senior Quality Engineer plays a key role in the creation of our market-leading portfolio of innovations.
The ideal candidate will have a proven track record of delivering high-quality products and services, and will be able to lead a global operations team responsible for shaping the manufacturing architecture to successfully develop and launch new products.
The Senior Quality Engineer Manager represents Quality as the Quality Core Team Representative (QCTM) and is the primary interface to the New Product Development & Operations Core team.
The role requires strong communication and leadership skills, with the ability to coach and develop extended team members to help individuals advance their skills and careers.
Main Responsibilities
1. Lead the Extended Operations Team comprising of Supply Management, Supplier Quality, Manufacturing Engineering, Process Development, Packaging and Supply Chain to ensure on-time and on-budget performance through the new product development cycle.
2. Champion the Voice of Quality as well as drive planning and execution to ensure scope, schedule and budget alignment between operations and core team functions.
3. Track and Manage Quality KPI's Lead Design Transfer and Commercial Build Readiness to ensure quality system compliance to achieve production readiness and successful product launches.
4. Manage CAPA execution, TMV development, statistical data analysis, and risk assessment Strong communicator with the ability to lead and Influence between Extended Operations Team and Core Team Coach and develop extended team members, to help individuals advance their skills and careers.
5. Provide performance feedback. Integrate Design for Reliability & Manufacturability (DRM) during product development as well as ensure structured problem methods and predictive engineering principles are consistently and rigorously applied.
Key Skills and Experience
* Minimum Requirements Bachelor's degree in engineering/science or a related discipline Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience
* Experience as a Program Manager leading large scale new product development programs Proven New Product Development Quality & Post Market Quality experience with depth of knowledge in at least two Operations functions Nice to Have Advanced degree in engineering/science or a related discipline Medical Device product development or operations experience with catheters, sheaths or other disposable medical devices Preference given to candidates who have FDA Class 3/PMA device experience Program Management experience (PMP Certified), DRM, DFSS or Six Sigma Black Belt Certified