Manager, Quality Engineering

About the role

Stryker is hiring an Onsite Manager, Quality Engineering in Mahwah, New Jersey. The role leads 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.

Key responsibilities

• Lead the Quality Assurance team, giving technical guidance and quality oversight across manufacturing and operations, and supporting functions to drive continuous improvement and compliance.
• Partner with site leadership so products consistently meet customer expectations, regulatory requirements and quality standards.
• Develop, coach and retain a high-performing team while fostering inclusion, accountability, collaboration and engagement.
• Drive quality system compliance by helping set, communicate and maintain quality standards, requirements and responsibilities.
• Lead site readiness and support internal, corporate, notified body, FDA and other regulatory audits and inspections.
• Oversee nonconforming products, product and process deviations, risk assessments, corrective and preventive actions.
• Monitor quality performance indicators such as NCR, CAPA, compliance and operational quality metrics, and act on adverse trends.
• Support local and global Quality Operations strategies that improve product quality, efficiency, risk management and regulatory compliance.

Required profile

• 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 in a regulated industry.
• Minimum 3 years leading teams, projects or quality management activities.
• Experience in regulated manufacturing, including FDA and international quality standards compliance.
• Experience with quality systems, audits, investigations, corrective actions and process improvement.

Preferred qualifications

• Master's degree, MBA or Black/Green Belt Lean/Six Sigma certification.
• Experience leading quality teams, setting quality strategies and influencing cross-functional stakeholders.

The position is onsite with 10% travel; the stated pay range is $141,600 - $236,000 USD annually.