Senior Quality Incoming/Process Supervisor
Stryker
Senior Quality Incoming/Process Supervisor
Job Description
Work Flexibility: OnsiteWhat You Will DoLead 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 NeedRequired QualificationsBachelor’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 QualificationsExperience with corrective and preventive actions, nonconformance investigations, and root cause analysis methodologies.Experience supporting internal and external quality audits.Travel Percentage: 20%
Locations
- Costa Rica, Grecia
Skills Required
- Quality Engineeringintermediate
- Quality Management System Regulationsintermediate
- correctiveintermediate
Required Qualifications
- Bachelor’s degree in Engineering or a related technical field. (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. (experience, 5 years)
- Minimum 2 years of experience leading or supervising quality personnel. (experience, 2 years)
- Strong knowledge of Quality Management System Regulations, ISO 13485, and the Medical Device Single Audit Program (MDSAP). (experience)
- Advanced English proficiency, written and verbal. (experience)
- Advanced Spanish proficiency, written and verbal. (experience)
Preferred Qualifications
- Experience with corrective and preventive actions, nonconformance investigations, and root cause analysis methodologies. (experience)
- Experience supporting internal and external quality audits. (experience)
Responsibilities
- 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.
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