Work Flexibility: Onsite

We’re seeking a Senior Manager, Quality – Product Transfer to lead a high-performing team at the forefront of innovation in medical device manufacturing.

In this hands-on leadership role, you’ll 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

What You Will Do:

Sets direction: Drives the execution of Product Transfer strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability.Builds organizational capability: Promotes the optimization of inspection strategies for launch through technology, automation, and supplier certification. Enables the development of lean inspection strategies, enabling lower inspection cost per unit.Inspires others: Coaching and development of staff who champion quality assurance during the product transfer process, ensuring product transfers meet or exceed established metrics.Delivers results: 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.Collaborate with Regional QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global QA team.Communicate 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. ·Oversight and responsibility to ensure adherence to product quality performance indicators (supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is), in conjunction with other targets. Continuously monitors to assess opportunities for improvement.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.Influences processes towards validation versus manual verification, where possible. · Drives competency in metrology within the quality assurance team including interpretation of complex engineering drawings and understanding of geometrical dimensioning and tolerance.Ensures compliance to Stryker Corporate, GQO and external regulatory requirements.Drive process development, optimization, and validation in a regulated medical device environmentLead continuous improvement efforts and share best practices across global teams

What You Need:

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.Experience in multiple areas / sites/ positions in the quality organization is advantageous.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.

Travel Percentage: 20%