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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.