Lead technical services activities across Metrology, Microbiology, Receiving Inspection, and related laboratory operations to ensure compliance with quality and regulatory requirements.
Manage and develop a team of engineers and quality professionals, supporting talent growth, performance management, and organizational scalability.
Oversee investigations of complex product and process quality issues using root cause analysis methodologies and corrective and preventive action processes.
Provide subject matter expertise in microbiology, sterilization, calibrations, receiving inspection, and quality systems.
Monitor quality performance metrics, including defects, yield, scrap, nonconformances, and complaints, and implement improvement actions based on data analysis.
Ensure compliance with applicable regulatory and quality standards, including Quality Management System Regulation, ISO 13485, and Medical Device Single Audit Program requirements.
Support cross-functional projects, laboratory expansion initiatives, and operational readiness activities while meeting project timelines and deliverables.
Serve as the operational backup for the Technical Services leader, ensuring continuity of decision-making, prioritization, and execution across the organization.
What You Will Need
Required Qualifications
Bachelor’s degree in Engineering or a related technical field.
Minimum 7 years of experience in Quality Engineering, Technical Services, Microbiology, Sterilization, Calibrations, Receiving Inspection, or related quality functions within a regulated industry.
Minimum 2 years of people leadership experience.
Knowledge of Quality Management System Regulation (QMSR), ISO 13485, and Medical Device Single Audit Program (MDSAP) requirements.
Experience leading root cause investigations, corrective and preventive actions, and nonconformance management processes.
Fluent English proficiency.
Preferred Qualifications
Experience in the medical device industry.
Experience managing laboratory operations, quality systems, or technical services teams in a manufacturing environment.