Senior Quality Engineer

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

What You Will Do

• Lead investigations of non-conformances and implement corrective and preventive actions to support timely issue resolution.
• Collaborate with Engineering, Production, and cross-functional teams to ensure products and processes meet quality requirements.
• Support internal and external audits by preparing documentation, participating in audit activities, and addressing audit observations.
• Escalate quality concerns to Quality Assurance and Engineering leadership and support resolution activities.
• Manage containment activities for non-conforming product, including identification, segregation, documentation, and reconciliation.
• Monitor, analyze, and trend quality data to identify risks, recurring issues, and improvement opportunities.
• Ensure compliance with the Quality Management System and applicable regulatory requirements.
• Apply statistical analysis and risk management tools, including Failure Mode and Effects Analysis (FMEA), to support decision-making and continuous improvement initiatives.

What You Will Need

Required Qualifications

• Bachelor's degree in Engineering or a related technical field.
• Minimum 3 years of experience in Quality Engineering.
• Working knowledge of 21 CFR Part 820, ISO 13485, and the Medical Device Single Audit Program (MDSAP).
• Advanced English proficiency, written and verbal.

Preferred Qualifications

• Experience supporting internal and external quality audits.
• Experience conducting investigations, risk assessments, and corrective and preventive action activities.
• Experience working in a regulated manufacturing environment.
• Experience using statistical analysis and quality risk management tools.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.