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Stryker
Manager, Quality Engineering
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Job Description
As the Manager, Quality Assurance , you will lead quality assurance activities that support product quality, process performance, audit readiness, and continuous improvement across site operations. Working closely with Operations, Global Quality, Regulatory Affairs, and supplier partners, you will help ensure quality systems remain effective, compliant, and aligned with business objectives. This role is Onsite in Mahwah, New Jersey . What You Will Do Lead the Quality Assurance team, providing technical guidance and quality oversight across manufacturing and operations, supports functions to drive continuous improvement and compliance. Partner with site leadership to ensure products consistently meet customer expectations, regulatory requirements, and applicable quality standards. Develop, coach, and retain a high-performing team while fostering a culture of inclusion, accountability, collaboration, and employee engagement. Drive quality system compliance by partnering with functional leaders to establish, communicate, and maintain quality standards, requirements, and responsibilities. Lead site readiness activities and support internal, corporate, notified body, FDA, and other regulatory audits and inspections. Oversee the management of nonconforming products, product and process deviations, risk assessments, corrective actions, and preventive actions to ensure effective resolution and compliance. Monitor and improve Quality performance indicators, including NCR, CAPA, compliance, and operational quality metrics, and implement corrective actions for adverse trends. Support the development and execution of local and global Quality Operations strategies that improve product quality, operational efficiency, risk management, and regulatory compliance. What You Need Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline. Minimum 6 years of experience in a technical, manufacturing, quality, or engineering role within a regulated industry. Minimum 3 years of experience leading teams, projects, or quality management activities. Experience working within a regulated manufacturing environment, including compliance with FDA and/or international quality standards. Experience supporting quality systems, audits, investigations, corrective actions, and process improvement initiatives. Preferred Qualifications Master's degree in Business Management, Engineering, Science, or an MBA. Experience leading and developing high-performing quality teams in a manufacturing environment. Experience establishing quality strategies and performance improvement programs across multiple sites or business units. Black Belt, Green Belt, or equivalent Lean/Six Sigma certification. Experience supporting global quality systems, regulatory compliance initiatives, and continuous improvement programs. Experience influencing cross-functional stakeholders and driving quality culture initiatives.