Supervisor III MQE

About the role

A MQE Supervisor uses engineering expertise to address product quality issues and to implement advanced technical solutions that meet quality goals. The role is based in Costa Rica with up to 20% travel and works closely with site quality leaders.

Key responsibilities

• Develop and implement world‑class quality processes within the Quality Management System (QMS) to support business requirements.
• Lead the evolution of the site QMS as the facility matures from component to finished device manufacturing.
• Ensure all QMS elements (management reviews, internal audits, supplier management) comply with global quality procedures.
• Represent Global Quality in customer meetings, business proposals and quarterly business reviews.
• Plan, conduct, communicate and report on global internal audit results.
• Coordinate with the Project Management Office on NPI transfers that may impact the QMS.
• Support implementation of electronic quality systems and approve engineering change orders (ECO), document change orders (DCO) and training matrices.

Required profile

• Experience in process compliance and quality system auditing.
• Strong problem‑solving, research and report‑writing abilities with attention to detail.
• Ability to manage multiple tasks, work independently and prioritize initiatives.
• Proven Lead Auditor experience conducting ISO 13485 and FDA‑based audits.
• Excellent communication and interpersonal skills.
• Knowledge of ISO 13485 and FDA quality requirements.

Required skills

• ISO 13485 compliance
• FDA quality regulations
• Quality System Audits
• Lead Auditor certification
• Internal audit execution
• NCMR/CAR/CAPA handling
• ECO/DCO approval processes
• Electronic quality system implementation