Quality Operations Leader for Regulated Manufacturing

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

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