QA Engineering Manager: Manufacturing Quality & Compliance

Stryker; Mahwah (NJ); On-site; USD 142,000 - 236,000; Full time

Job summary

Stryker is seeking a Manager of Quality Assurance in Mahwah, New Jersey, onsite. You will lead QA activities to ensure product quality, process performance, audit readiness, and continuous improvement across site operations.

You will partner with Operations, Global Quality, Regulatory Affairs, and suppliers to keep systems compliant and effective. Responsibilities include guiding the QA team, driving quality system standards, leading audits, and managing NCR/CAPA processes.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline.
• Minimum 6 years in a technical, manufacturing, quality, or engineering role within a regulated industry.
• Minimum 3 years leading teams, projects, or quality management activities.
• Experience in regulated manufacturing including FDA or international quality standards.
• Experience supporting quality systems, audits, investigations, CAPA, and process improvement.

Responsibilities

• Lead the Quality Assurance team, providing technical guidance and quality oversight across manufacturing and operations.
• Partner with site leadership to ensure products 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 establishing, communicating, and maintaining quality standards and responsibilities.
• Lead site readiness activities and support audits and inspections (FDA, corporate, notified body, etc.).
• Oversee nonconforming products, deviations, risk assessments, CAPA, and corrective actions.
• Monitor quality metrics (NCR, CAPA, compliance) and implement actions for adverse trends.
• Support local and global Quality Operations strategies to improve product quality and regulatory compliance.

Skills

Quality Assurance

Leadership

Regulatory Compliance

Audits

CAPA

NCR

Process Improvement

Education

Bachelor's degree

Master's degree (preferred)

Tools

Lean Six Sigma

Job description

Stryker is seeking a Manager of Quality Assurance in Mahwah, New Jersey, onsite. You will lead QA activities to ensure product quality, process performance, audit readiness, and continuous improvement across site operations.

You will partner with Operations, Global Quality, Regulatory Affairs, and suppliers to keep systems compliant and effective. Responsibilities include guiding the QA team, driving quality system standards, leading audits, and managing NCR/CAPA processes.