Manager, Quality Assurance (Fixed Term - 18 months)

Stryker Corporation; Sandy Springs (GA); On-site; USD 118,000 - 197,000; Full time

Job summary

Stryker Corporation in Georgia seeks a Manager of Quality Operations to lead quality activities across manufacturing and operations, driving improvement and ensuring regulatory compliance.

The role partners with site leadership, develops a high-performing team, and oversees audits by FDA and other bodies, with emphasis on CAPAs, NCRs, and quality metrics. Onsite role with strong cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• Minimum 6 years in a medical device or regulated manufacturing environment.
• Experience leading quality assurance/operations in a regulated industry.
• Experience supporting FDA inspections and regulatory audits.
• Knowledge of quality regs, QMS, and quality tools (SPC, FMEA, RCA, Six Sigma).

Responsibilities

• Lead Quality Assurance team with technical guidance and quality oversight.
• Partner with site leadership to ensure products meet customer, regulatory, and quality standards.
• Develop and coach a high-performing team and foster inclusion and collaboration.
• Drive quality system compliance and establish quality standards and responsibilities.
• Lead site readiness activities and support FDA and other regulatory audits.

Skills

Quality leadership

Regulatory knowledge

Audits experience

Continuous improvement

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Master's degree (preferred)

MBA (preferred)

Tools

SPC

FMEA

Root Cause Analysis

Six Sigma

Job description

Work Flexibility: Onsite The Manager, Quality Operations will oversee quality-related activities within the Quality Operations structure in a management capacity, including 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: $118,000 - $196,700 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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.