Onsite Quality Engineering Manager - Lead QA & Compliance

Stryker Corporation; Mahwah (NJ); Hybrid; USD 142,000 - 236,000; Full time

Job summary

Stryker Corporation is seeking a Manager, Quality Assurance in Mahwah, New Jersey. This onsite role leads the QA team to ensure product quality, regulatory compliance, and continuous improvement across site operations.

You will collaborate with Operations, Global Quality, Regulatory Affairs, and suppliers to ensure quality systems remain effective and audits are passed. A strong leadership track record and deep quality expertise are essential.

Qualifications

• 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.

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 and regulatory requirements.
• Develop, coach, and retain a high-performing team fostering inclusion and engagement.
• Drive quality system compliance by establishing and maintaining quality standards and responsibilities.
• Lead site readiness activities and support audits and inspections by regulators.
• Oversee management of nonconforming products, deviations, risk assessments, CAPA.
• Monitor and improve quality performance indicators and implement corrective actions for trends.
• Support the development and execution of local and global Quality Operations strategies.

Skills

Leadership

Quality management

Regulatory compliance

Audits

Process improvement

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, Manufacturing, or related technical discipline

Job description

Stryker Corporation is seeking a Manager, Quality Assurance in Mahwah, New Jersey. This onsite role leads the QA team to ensure product quality, regulatory compliance, and continuous improvement across site operations.

You will collaborate with Operations, Global Quality, Regulatory Affairs, and suppliers to ensure quality systems remain effective and audits are passed. A strong leadership track record and deep quality expertise are essential.