Quality Engineer 2 – On‑Market Medical Devices

About the role

Hologic is seeking a Quality Engineer 2 to provide engineering support for on‑market medical devices. Working the B shift (2 pm‑10 pm, Monday‑Saturday) on‑site in Alajuela, you will collaborate with cross‑functional teams to drive process improvements, assess risks and ensure product quality and patient safety.

Key responsibilities

• Plan, coordinate, validate and implement process improvements in line with regulatory quality requirements.
• Provide technical support, engineering‑tools training and mentorship to Quality Engineers 1 and Quality Engineering Analysts.
• Lead containment meetings, assess impact risks and develop action plans to mitigate quality issues on manufacturing lines.
• Coordinate interdisciplinary CSPO teams, maintain communication and facilitate decision‑making affecting product and line performance.
• Investigate product failures, customer complaints and non‑conformances, and drive corrective and preventive actions.
• Review, update and approve documentation, change orders and protocols to ensure continuous improvement of the quality system.
• Develop and execute validations to confirm compliance with regulations, standards and best practices.

Required profile

• Proactive problem‑solver with a strong background in quality engineering.
• Experience working with on‑market medical devices and regulatory quality requirements.
• Ability to lead teams, communicate effectively and drive cross‑functional initiatives.

Required skills

• Process improvement
• Risk assessment
• Root‑cause analysis
• Validation and verification
• Quality control and quality engineering
• Regulatory compliance (medical device standards)