Quality Operations Lead - Medical Devices

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

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.