Operational Quality Auditor

Job Overview Hologic, Inc. is seeking an Operational Quality Auditor to join their team in Alajuela, Costa Rica. This role is crucial for ensuring that all operational processes adhere to the highest quality standards, contributing to the company’s mission of enabling healthier lives everywhere, every day. Company Overview Hologic, Inc. is an innovative medical technology company dedicated to advancing women’s health and well-being globally. They discover and develop groundbreaking products and services in Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions. Hologic’s clinically proven products detect, diagnose, and treat illnesses earlier and more effectively, driven by a commitment to improving health through better technology, education, and market access. Quick Details

Salary Range: Market Competitive Job Type: Full-time Qualifications: None Experience: 3 Year+

Key Responsibilities

Conduct thorough operational audits to ensure strict adherence to internal quality standards and external regulations. Identify and document non-conformities, root causes, and potential areas for process improvement. Develop and recommend corrective and preventive actions (CAPAs) to address audit findings. Collaborate with cross-functional teams to implement and monitor the effectiveness of quality control measures. Prepare detailed audit reports and present findings and recommendations to management. Participate in continuous improvement initiatives for the company’s quality management system.

Requirements

Proven experience in quality assurance, auditing, or a related field within a manufacturing environment. Strong understanding of quality management systems (e.g., ISO 13485, FDA regulations for medical devices). Excellent analytical skills with a keen eye for detail and problem-solving abilities. Ability to communicate effectively, both verbally and in writing, in English and Spanish. Proficiency in generating comprehensive audit reports and documentation. Commitment to maintaining high ethical standards and regulatory compliance.

Benefits

Opportunity to work for a global leader in medical technology focused on women’s health. Engaging and dynamic work environment in Alajuela, Costa Rica. Professional development and continuous learning opportunities. Contribute directly to products that significantly improve patient outcomes. Competitive compensation package. Collaborative culture that values innovation and employee contributions.