Manager, Quality Assurance (Fixed Term - 18 months)

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

Job summary

Stryker Group is seeking a Manager, Quality Operations to lead the QA team and ensure compliant operations across manufacturing and related functions. You will collaborate with site leadership to uphold customer expectations and regulatory standards, while driving a culture of inclusion and accountability.

The role requires a Bachelor's in a technical field, 6+ years in a regulated environment, and hands-on experience with FDA inspections, CAPAs, and quality tools such as SPC, FMEA, and Six

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.

Responsibilities

• Lead the Quality Assurance team, providing technical guidance and quality oversight.
• Partner with site leadership to ensure products meet customer expectations and regulatory requirements.
• Develop, coach, and retain a high-performing team with a culture of inclusion and accountability.
• Drive quality system compliance with functional leaders and quality standards.
• Lead site readiness and support FDA inspections and other audits.
• Oversee nonconformances, CAPAs, deviations, risk assessments, and RCAs.
• Monitor Quality performance indicators and implement corrective actions for adverse trends.

Skills

Leadership

Regulatory mindset

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Science/related technical discipline

Tools

SPC

FMEA

Root Cause Analysis

Six Sigma

Job description

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

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