Quality Engineer
- Company: Stryker
- Location: Grecia, Costa Rica
- Work mode: On-site
- Job type: Full-Time
- Posted: 2026-10-17
Work Flexibility: Onsite
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.
Travel Percentage: None