What you will do:

As a global partner & leader of the Regional Quality Assurance (QA) NPI team, this role, advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance for new product launches. This leader will influence the development and introduction of new products, processes, and technologies, with focus on process risk management including robust pFMEA to deliver highest quality products at launch.

Working within the regional NPI Quality structure, in a leadership capacity, has responsibility for quality related activities, including, but not limited to the following:

• Sets direction: Drives the execution of new product development strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability.
• Builds organizational capability: Promotes the optimisation 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 development process, ensuring product launches 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.
• Drives robust pFMEA and critical to quality attributes (CQA) identification to deliver accurate process risk identification, process characterization, process validation, process capability, robust process control and supplier capability.
• Fosters collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with new product launch.
• Collaborate with Regional NPI QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global NPI QA team.
• Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful New Product Introductions that meet the NPI 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 per the design transfer agreement plan (DTAP). Continuously monitors to assess opportunities for improvement.
• Ensures effective processes in selection of competent talent and supports the development of future potential experts and leaders. Ensures effective training and performance management processes are in place and executed.
• Advocates for the design of robust inspection strategies including CQA’s, CTQ’s and test method validations.
• 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 NPI team including interpretation of complex engineering drawings and understanding of geometrical dimensioning and tolerance.
• Ensures compliance to Stryker Corporate, GQO and external regulatory requirements.

• Bachelor’s Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage.
• Minimum of 6 years’ experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
• 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.