Quality Assurance Specialist

Kerecis is the fastest-growing company in the world in the field of wound treatment, building its technology on the utilization of cod skin and fatty acids. Kerecis' medical products are used for the treatment of various bodily injuries, including surgical wounds, chronic wounds, and burns, to accelerate healing and strengthen tissue after surgery and accidents. Kerecis is part of the Coloplast group, and Kerecis employees work for the company in Ísafjörður, Reykjavík, Europe, and the United States. Kerecis products contribute to the recovery of thousands of individuals worldwide annually. Quality Assurance Specialist Job Description We are looking for a qualified and meticulous individual to join our team at Kerecis, a leading company in medical device manufacturing. You will play a crucial role in ensuring the quality and compliance of medical products with applicable quality requirements and regulations. Key Responsibilities: - Implement, maintain, and continuously improve Kerecis' quality management system to ensure compliance with standards (e.g., ISO 13485) and regulations (e.g., EU-MDR, FDA-QMSR, MDSAP) for the manufacturing, distribution, and sale of medical products worldwide. - Organize and conduct internal/external audits and inspections to assess adherence to quality standards, regulatory requirements, and company policy. - Manage the CAPA system (corrective and preventive actions) and oversee related tasks. - Oversee document control processes, ensuring quality documents, procedures, and records are accurately maintained, updated, and accessible. - Collaborate across teams to drive continuous improvement. - Lead the resolution of quality issues, deviations, and customer complaints. - Contribute to risk assessment and risk management. - Compile quality metrics and reports for management. Requirements: - Bachelor's degree or experience in a relevant field (e.g., quality management, engineering, biology, or pharmacy). - Experience and knowledge within the medical device industry is an advantage. - Strong knowledge of FDA regulations (21 CFR Part 820) and ISO standards (ISO 13485) is an advantage. - Good analytical skills and solution-oriented thinking. - Effective communication and teamwork skills. - Experience and education in quality management is an advantage. Benefits of working at Kerecis: - Opportunities for professional development and growth. - Collaborative and innovative work environment in a fast-growing international company owned by Coloplast. - Making a significant impact with a first-class medical product. If you have a strong passion for quality matters and work related to medical products that make a difference in the healthcare sector, we invite you to apply for the QA Specialist position at Kerecis. Join our mission to deliver high-quality medical products that improve patient outcomes. Further information about the position can be provided by Ína Björg Össurardóttir, Head of Quality Assurance (ibo@kerecis.com).