Quality Engineer II at Heraeus Medevio developing engineering solutions for manufacturing complaints and quality issues. Leading teams to improve product and process quality in Cartago, Costa Rica.
About the role
- Associate Manager managing Stryker’s Quality Management System and coordinating quality assurance tasks. Ensuring compliance with ISO standards and supporting audits.
Responsibilities
- Manage and maintain Stryker’s Quality Management System.
- Support internal and external audits.
- Ensure processes meet ISO 9001 and ISO 13485 standards.
- Coordinate quality assurance tasks, including auditing and certification processes.
- Administer and implement the Quality Management System (CAPAs, deviations, change control, risk analysis, document control, complaints).
- Execute internal audits and participate in external audits, following up on corrective actions.
- Develop and implement continuous improvement programs focused on efficiency and regulatory compliance.
- Manage and monitor warehouse processes from a quality perspective.
- Implement local, regional, or global processes as required by the quality system.
- Monitor key performance indicators (KPIs) and manage field action, product retention, and recall processes.
Requirements
- Required Bachelor’s degree in Engineering or a related field.
- 3 to 5 years of experience in quality assurance and quality management functions.
- Experience in the medical device industry and other regulated environments.
- Proven experience with Quality Management Systems based on ISO 9001 and ISO 13485.
- Experience as a lead auditor.
- Advanced English.
- Proficiency in Microsoft Office.
- Preferred Experience with quality management tools and ERP systems (Trackwise or similar).
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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