Senior Quality Engineer: CAPA & Compliance Leader

PowerToFly; Town of Greece (NY); On-site; USD 85,000 - 120,000; Full time

Job summary

Stryker is seeking a Quality Engineer to lead investigations of non-conformances and drive CAPA activities while collaborating with Engineering, Production, and cross-functional teams to ensure products meet strict quality standards.

Role emphasizes audit support, containment of non-conforming product, data trend analysis, and application of FMEA for risk-based decision making. Strong regulatory knowledge and English proficiency are essential for success.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• At least 3 years of experience in Quality Engineering.
• Working knowledge of 21 CFR Part 820, ISO 13485 and MDSAP.
• Advanced English proficiency, written and verbal.

Responsibilities

• Lead investigations of non-conformances and implement corrective and preventive actions.
• Collaborate with Engineering, Production, and cross-functional teams to meet quality requirements.
• Support internal and external audits with documentation and addressing observations.
• Escalate quality concerns to QA and Engineering leadership and support resolutions.
• Manage containment activities for non-conforming product and reconcile records.
• Monitor and trend quality data to identify risks and improvement opportunities.
• Ensure compliance with QMS and regulatory requirements.
• Apply FMEA and risk management tools to support decisions and continuous improvement.

Skills

Quality Engineering

Regulatory knowledge

Statistical analysis

English communication

Education

Bachelor's degree in Engineering

Tools

FMEA

Quality management systems

ISO 13485

Job description

Stryker is seeking a Quality Engineer to lead investigations of non-conformances and drive CAPA activities while collaborating with Engineering, Production, and cross-functional teams to ensure products meet strict quality standards.

Role emphasizes audit support, containment of non-conforming product, data trend analysis, and application of FMEA for risk-based decision making. Strong regulatory knowledge and English proficiency are essential for success.