Quality Assurance Specialist

This is a fully remote position, open to applicants in Spain.

📋 Description

• Oversee the regional Quality Compliance program implementation across EMEA.

• Create and uphold the yearly EMEA internal audit program, taking into account risk factors, regulatory requirements, and business priorities.

• Organize, execute, document, and report internal audits at various EMEA locations and departments.

• Track audit findings and assist site management in the prompt execution and resolution of CAPAs.

• Coordinate and facilitate audits and inspections from notified bodies, certification bodies, customers, and regulatory agencies.

• Compile and summarize inputs and reports for Management Review.

• Evaluate quality metrics and trends to aid Management Review discussions and facilitate decision-making.

• Assist in the maintenance and ongoing enhancement of the Quality Management System.

• Offer expertise on quality compliance requirements, audit preparedness, and best practices.

• Aid in the management of CAPA, quality risk, document control, change management, training compliance, and quality reporting.

• Collaborate with regional and global Quality teams to synchronize compliance efforts and quality goals.

• Foster a culture centered on quality, compliance, and continuous improvement.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related field.

• At least 3–5 years of experience in Quality Assurance, Quality Compliance, or Quality Systems within a regulated sector.

• Background in Medical Devices, Pharmaceuticals, Biotechnology, or similar regulated fields.

• Proven experience in planning and conducting internal audits.

• Familiarity with supporting external audits and regulatory inspections.

• Experience in preparing materials for management reviews and analyzing quality metrics.

• In-depth knowledge of Quality Management Systems and relevant regulations and standards, including ISO 13485, FDA QSR, and MDR or equivalent.

• Certification as an Internal Auditor is preferred.

• Proficient in English; knowledge of additional European languages is a plus.

• Willingness to travel within the EMEA region as necessary.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for reward and recognition.

• Competitive salary and benefits packages.

• Opportunities for learning, growth, and development.

• A collaborative culture that promotes face-to-face learning, progress, and success.