Quality Assurance Manager, NPI Transformation

Quality Assurance Manager, NPI Transformation

Our organization is seeking a Quality Assurance Manager to lead a high-performing team at the forefront of innovation in medical device manufacturing.

In this leadership role, you will play a pivotal part in our Product Transfer Quality team—mentoring engineers, guiding cross-functional collaboration, and ensuring every product transfer meets the highest standards of quality, safety, and regulatory compliance. Your work will directly shape the future of life-changing medical technologies.

Key Responsibilities:

• Develops and executes Product Transfer strategy to create highly capable processes resulting in high yield and enabling scalability.
• Promotes organizational capability through technology, automation, and supplier certification, enabling lean inspection strategies for launch.
• C coaches and develops staff who champion quality assurance during the product transfer process, ensuring product transfers meet or exceed established metrics.
• Oversight and responsibility to ensure appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process.
• Fosters collaborative internal/external professional relationships across Divisions and functions associated with Product Transfer.
• Collaborates with Regional QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global QA team.
• Ensures effective training and performance management processes are in place and executed.
• Communicates effectively with all internal customers, stakeholders, and project teams to deliver successful Product Transfers that meet the project goals as well as the regulatory requirements.
• Monitors opportunities for improvement in conjunction with other targets.
• Drives competency in metrology within the quality assurance NPI team including interpretation of complex engineering drawings and understanding of geometrical dimensioning and tolerance.
• Guides the team to onboard suppliers with demonstrated quality, process capability, and validation.
• Ensures robust supplier pFMEA, PPAP, supplier certification, and inspection methods where appropriate.
• Drives process development, optimization, and validation in a regulated medical device environment.
• Leads continuous improvement efforts and shares best practices across global teams.

Requirements:

• Bachelor's Degree in Engineering, Science discipline, or equivalent. Business Management or MBA is an advantage.
• Minimum of 10+ years' experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive, or regulated manufacturing environment.
• Minimum of 6+ years' experience and a proven track record of successfully creating and managing a highly talented, engaged, and performing team.
• Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other bodies.
• Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.
• Demonstrated leadership ability to develop and implement organization and functional strategy.
• Initiates, sponsors, and implements change with a demonstrated track record.
• Must be able to work in a team & individual environment, influencing effectively at all levels, and across all functions with ability to develop organizational relationship and build trust.
• Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency always.
• The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines.

About Us:

Our organization is a leading manufacturer of medical devices, dedicated to delivering innovative solutions that improve patient outcomes. We value diversity, equity, and inclusion, and strive to create a workplace culture that is respectful and inclusive for all employees.