Quality Assurance Associate Manager
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Mexico City • 🇲🇽 Mexico
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
ERP
About the role
- 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).
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management SystemISO 9001ISO 13485auditingcertification processesCAPAsdeviationschange controlrisk analysisdocument control
Soft skills
continuous improvementefficiencyregulatory compliancemonitoringcoordinationcommunicationleadership