Manager, Quality Engineering

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

Work Flexibility: Onsite

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.

United States of America Pay Ranges:

US20 : $141,600 - $236,000 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.