Quality & Regulatory Manager

Our client is a UK medical products manufacturer that specialise in the production of single use sterilisation barrier systems. Products include a comprehensive range of bags, pouches, reels, wraps and accessories for use in hospital sterile service departments and medical device manufacturers. Part of a larger group they are fast growing and looking to further develop their Quality & Regulatory capability.

As Quality & Regulatory Manager you will lead and manage Quality Assurance and Regulatory Compliance throughout the business and take overall responsibility for the quality of products released by the company, acting as the Person Responsible including environmental and health and safety.

The company will offer the chance to be part of a growing organisation where there are existing products/new products being developed where QARA is pivotal, a good package and hybrid working

• 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 customers
• The Quality & Regulatory Manager will be responsible for compliance with ISO 9001, ISO 13485 and Kitemark certification requirements
• Management and leadership of QARA and QC departments, including mentoring of staff
• Work with the department heads for the continued development of a quality assurance culture e.g. training, working with the production team to improve quality, improvements to production processes and continuous improvement activities
• The Quality & Regulatory Manager will lead internal and supplier audits
• Support Health and Safety Management
• Lead Risk Assessments, including COSHH and hazard reviews
• Management of environmental policy
• Work with group companies to build synergies and standardised practices

• Quality Assurance &/OR Regulatory Management
• Quality Management System (QMS)
• Management of Health & Safety and Environmental systems (desirable)
• Supplier, customer and external agency liaison
• Degree level education OR track record in a similar role
• Lead Auditor or Internal Auditor training
• NEBOSH / IOSH Health and Safety - desired but not compulsory
• Knowledge and understanding of QARA in either Medical Device, Pharmaceutical or Biotech manufacture

On offer

• Excellent salary, bonus and existing team
• Hybrid working if needed (3 days onsite)
• One of the most idyllic workplaces in the industry

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