Senior Quality Assurance Engineer

About the role

We are seeking a Senior Quality Assurance Engineer to support and drive quality initiatives for our medical device manufacturing operations in Alajuela. You will ensure products, processes, and validations meet regulatory standards while fostering continuous improvement.

Key responsibilities

• Provide support in quality statistics and engineering, including sampling plans, dimensional tolerances, inspection methodologies, GR&R analyses, validations, qualifications, and transfers.
• Manage and resolve product‑related non‑conformances and deliver training on non‑conforming product control and quarantine processes.
• Generate and close Corrective and Preventive Actions (CAPA) for products and processes.
• Coordinate continuous improvement activities in manufacturing and inspection/quality processes.
• Lead failure analyses and corrective actions in response to customer complaints.

Required profile

• Bachelor’s degree in Engineering or a related field.
• More than 5 years of experience in Quality Engineering within the medical device industry.
• Advanced English proficiency (B2+).
• Desirable certifications: CQE, Green Belt or Six Sigma Black Belt.
• Proficiency with Microsoft Office and statistical software.

Required skills

• Microsoft Office
• Statistical software

What we offer

• Stock purchase program, referral bonus, transportation and food subsidies.
• Additional days off, birthday off, and volunteer hours.
• Health benefits including company physician, gym access, life insurance, legal, psychological and financial assistance.
• Flexible schedules with the possibility of remote work depending on role functions.
• Training programs and unlimited learning tools.