QA Specialist - Medical Devices

An exciting opportunity has arisen for a QA Specialist to focus specifically on Medical Devices. The role based in Iceland is great chance to build your portfolio with a leading pharmaceutical company.

Job Responsibilities

• Drive simplification & standardization of the QMS in line with overall quality strategies & initiatives
• Establish international and regional /local relationships with RA, other QA Groups, Manufacturing, Development and Management
• Ensure continuous regulatory knowledge as necessary for the business.
• Host and manage site audits
• Manage relationship with health authorities
• Maintain oversight of customer feedback and post marketing activities (e.g. complaints, FSCAs, recalls)
• Maintain oversight of supplier monitoring program
• Perform internal and external audits
• Maintain oversight of training program
• Record and manage quality issues, escalating serious events to senior management
• Lead Medical Device management review process and quality planning
• Lead and/or participate in quality/compliance/regulatory projects

Skills and Requirements

• Bachelor's Degree education in Pharmaceuticals, Law, Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality/Regulatory leadership roles.
• 5 years experienced working with EU, FDA, ISO 13485, ISO 14971 and other global Medical Device regulations
• Strong collaboration skills and ability to build partnerships internally and externally
• Experience of working directly with competent authorities
• Change management experience and influencing skills
• Track record of leading teams and driving results

To Apply

In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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