Manager, Quality Engineering

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

## Manager, Quality EngineeringApply: Mahwah, New Jersey: Full time: Posted Today: R574287Work Flexibility: OnsiteAs 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.