Quality Engineer, EU MDR

United Pharma is a company focused on the medical device industry, and they are seeking a Quality Engineer to support EU MDR remediation programs. The role involves leading cross-functional remediation activities, assessing compliance gaps, and implementing effective corrective actions within established timelines.

Requirements:

• Experience supporting EU MDR remediation programs within orthopedic, spine, or other implantable medical device product lines
• Working knowledge of ISO 13485, ISO 14971, and applicable EU MDR guidance documents
• Demonstrated experience leading cross-functional remediation activities and driving project deliverables to completion within established timelines
• Strong analytical and problem-solving skills with the ability to assess compliance gaps and implement effective corrective actions
• Experience with product risk assessments, technical file remediation, and post-market surveillance activities
• Proficiency in quality and compliance tools, including CAPA, change control, nonconformance management, and document control systems
• Effective project management skills with the ability to prioritize multiple activities in a fast-paced regulatory environment
• Excellent interpersonal, communication, and stakeholder management skills
• ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or related quality certifications