Quality Compliance Specialist 1

Join our team as a QMS Specialist and play a key role in building and strengthening a compliant, effective Quality Management System (QMS). In this role, you’ll collaborate across teams, support audits, and help drive continuous improvement initiatives that ensure quality and compliance across the business.

Your role:

• Support the deployment and continuous improvement of QMS processes, such as document control, training, and audits, ensuring compliance with regulatory standards.
• Partner with cross-functional teams and stakeholders to resolve quality issues through data-driven root cause analysis and corrective actions.
• Track and report QMS performance metrics—including non-conformances, audit findings, and training completion rates—to guide decision-making and identify improvement opportunities.
• Assist in planning and organizing internal audits, preparing documentation, supporting audit teams, and ensuring timely completion of follow-up actions.
• Maintain and archive quality records in compliance with QMS procedures, regulatory requirements, and company policies, ensuring ongoing audit readiness.

You're the right fit if:

• You’ve acquired 3+ years of experience in the medical device, biologics, or pharmaceutical industry, with knowledge of quality compliance, audit, or manufacturing processes.
• Your skills include root cause analysis, CAPA, regulatory requirements (21 CFR Parts 803, 806, 820; ISO13485; EU MDR; ISO9001), and experience with QMS tools and processes.
• You have a bachelor’s degree (or equivalent combination of education and experience). A Lead Auditor certification is a plus.
• You’re an effective communicator (fluent in English, written and verbal), detail-oriented, and eager to contribute to continuous improvement while working independently under general supervision.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

Additional Information

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Alajuela, Costa Rica**.

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