Work Flexibility: Hybrid
**What you will do**
In this role, the Associate Manager will manage and maintain Stryker's Quality Management System, support internal and external audits, and ensure our processes meet ISO **** and ISO ***** standards.
Will be responsible for coordinating quality assurance tasks, including auditing and certification processes.
This position has two direct reports.
**Key responsibilities**:
- Administer and implement the Quality Management System (CAPAs, deviations, change control, risk analysis, document control, complaints), ensuring maintenance and compliance with ISO **** and ISO *****.
- Coordinate and execute internal audits and participate in external audits, following up on corrective actions and improvement opportunities.
- Develop and implement continuous improvement programs focused on efficiency and regulatory compliance.
- Manage and monitor warehouse processes from a quality perspective and in accordance with applicable regulations.
- Implement local, regional,



or integral processes as required by the quality system.
- Monitor local and regional key performance indicators (KPIs).
- Manage field action, product retention, and recall processes, coordinating communication with suppliers and manufacturing sites.
- Supervise and collaborate on quality system-related training.
**What you need**
**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 **** and ISO *****.
- Experience as a lead auditor.
- Advanced English.
- Proficiency in Microsoft Office.
**Preferred**
- Experience with quality management tools and ERP systems (Trackwise or similar).
Travel Percentage: 20%

📌 Quality Assurance Associate Manager (Hybrid) (Xico)
🏢 Stryker
📍 Xico