Quality and Regulatory Affairs Manager

Location: Somerset  |  Somerset  |  England
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHQ&RAM
Salary: £40000 - £48000
Job Status: Permanent / Full Time

Quality and Regulatory Affairs Manager

Salary £40,000 – £45,000pa

We are looking for a driven and highly motivated Quality and Regulatory Manager.

This is an excellent opportunity for a forward-thinking individual, with a proven 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 throughout the business, and to take responsibility for the overall quality of products released by the company, ensuring first class customer service. This will include Environmental and Health & Safety responsibilities.

Main Responsibilities will include but are not limited to:

  • Overall responsibility for the administration and development of the Quality Management System
  • Management of Non-Conformances, including root cause analysis, corrective actions and timely response to the customer
  • Compliance with ISO 9001:2015 and ISO 13485:2016 certification requirements
  • Working with the other department heads for the continued development and introduction of a Quality Assurance culture, including but not limited to:
    • Management, further development and training of the Quality Control 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, leading to improved product quality and customer satisfaction
    • Involvement in company-wide continuous improvement activities
    • 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/Experience required:

  • Have minimum of 5 years’ experience of:
    • A Quality Management role with a Quality Management System, ideally to ISO 13485:2016 and ISO 9001:2015, or comparable in complexity and process detail
    • Microsoft Office applications
    • Management of Health & Safety and Environmental systems.
    • Have.
    • Be a confident and effective communicator with excellent numeracy and literacy skills.
    • Possess excellent leadership skills with the ability to influence and manage change.
    • Will enjoy working in a fast-paced environment and be highly organised with the ability to multi-task, time manage and take on new information at a high level.
    •  

Education / Qualifications;

  • Minimum HND / NVQ qualification
  • NEBOSH / IOSH Health and Safety
  • Relevant Auditor training