Senior Manager, Quality Assurance, New Product Introduction

• 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.
• 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 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.

Stryker