Quality & Regulatory Affairs Manager

Our client a fast growing medical device manufacturer based in the South West are looking to add a Quality & Regulatory Affairs Manager the company.

This is an excellent opportunity for someone with a track record, to take the business forward in line with the company's growth plans.

The primary focus of this role will be to lead Quality Assurance and Regulatory Compliance and to take responsibility for the overall quality of products released, ensuring customer service. This will include Environmental and Health & Safety responsibilities.

Responsibilities:

• Administration and development of the Quality Management System
• Management of Non-Conformance, including root cause analysis, corrective actions and timely response to customers
• Compliance with ISO 9001 and ISO 13485 certification requirements
• Compliance with requirements of the Medical Devices Regulation
• Working with department heads for the continued development of a Quality Assurance culture, including but not limited to:
  • Management, development and training of the Quality department to ensure suitable testing and inspection processes are applied at the relevant points of the process
  • Working with the production team to implement effective solutions to quality issues
  • Support improvements to production processes, thereby improving product quality and customer satisfaction
  • Involvement in company-wide continuous improvement activities
• Internal training related to QMS, Product Quality and Product Awareness
• Internal and supplier audits
• Management of Health and Safety policy, documentation and meetings
• Risk assessments, including COSHH and hazard reviews
• Management of environmental policy, waste tracking and environmental monitoring

Skills/Qualifications:

• Quality Management role within the Medical Device or Life Sciences, ideally to ISO 13485 and ISO 9001.
• Management of Health & Safety and Environmental systems
• Supplier, customer and external liaison
• leadership skills with ability to influence and manage change
• NEBOSH / IOSH Health and Safety
• Relevant Auditor training

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales