Job Description

Work Flexibility: Onsite

What You Will Do

• Lead and supervise Quality Control teams responsible for incoming, in-process, and finished product inspections, document review, and validation testing.
• Manage daily quality operations across shifts to support manufacturing goals, product release timelines, and regulatory compliance.
• Review and approve quality records, inspection results, and batch documentation in accordance with established procedures.
• Coordinate product holds, product disposition activities, nonconformance investigations, and corrective action implementation.
• Monitor quality metrics and nonconformance trends to identify risks, drive process improvements, and support data-based decision making.
• Develop, train, and evaluate Quality Control personnel to ensure consistent execution of quality processes and procedures.
• Partner with Engineering, Manufacturing, and other functions to communicate quality requirements, provide training, and support product and process improvements.
• Support internal and external audits and maintain compliance with applicable quality system and regulatory requirements.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 5 years of experience in Quality Engineering, Quality Control, or Quality Assurance within a regulated manufacturing environment.
• Minimum 2 years of experience leading or supervising quality personnel.
• Strong knowledge of Quality Management System Regulations, ISO 13485, and the Medical Device Single Audit Program (MDSAP).
• Advanced English proficiency, written and verbal.
• Advanced Spanish proficiency, written and verbal.

Preferred Qualifications

• Experience with corrective and preventive actions, nonconformance investigations, and root cause analysis methodologies.
• Experience supporting internal and external quality audits.

Travel Percentage: 20%