Manager, Quality Assurance

Work Flexibility: Onsite

The Manager Quality Operations will work within the Quality Operations structure, in a management capacity, has responsibility for quality related activities which include, but not limited to the following:

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, Science, or a related technical discipline.
• Minimum 6 years of experience in a medical device, pharmaceutical, biomedical, automotive, or other regulated manufacturing environment.
• Experience leading quality assurance or quality operations activities within a regulated industry.
• Experience supporting FDA inspections, notified body audits, and other regulatory audits.
• Knowledge of global quality regulations, standards, and quality management systems.
• Working knowledge of quality tools including Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, and Six Sigma methodologies.
• Experience managing nonconformances, CAPAs, quality investigations, and risk assessments.
• Experience implementing quality improvement initiatives and driving organizational change.

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:

• USN: $102,600 - $171,000 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.