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Quality & Regulatory Affairs Manager

Real Staffing
Job LocationRadstock
EducationNot Mentioned
Salary55,000 - 65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client a fast-growing medical device manufacturer based in the Southwest of England in an idyllic location. They are looking to add a Quality & Regulatory Affairs Manager the leadership team at present. This is an excellent opportunity for someone witha track record, to take the business forward in line with the companys 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 (new and existing).Responsibilities:

  • Administration and development of the Quality Management System
  • Management of Non-Conformances, 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 (MDR)
  • 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
    • 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
  • 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 or Regulatory Affairs Management within the Medical Device or Life Sciences sectors
  • ISO 13485 and ISO 9001
  • Management of Health & Safety and Environmental systems
  • Supplier, customer and external liaison
  • Health and Safety
  • Relevant Auditor training
To find out more about Real please visit www.realstaffing.comReal 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 andWales

Keyskills :
ComplianceManagementMDRISO 13485qualitymanufacturingregulatorymedical devicecontinuous improvement

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