Group Head of Quality

☞ Ad Warrior

View: 107

Update day: 09-05-2024

Location: Ely East

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting

Position: Director

Job type: Full-time

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Job content

Location:Ely, CambridgeshireSalary:70,000 - 80,000 per annumOur client is a privately-owned company that was founded in 2005. Many years of continued growth and acquisition have developed the company into a leading healthcare and pharmaceutical provider across UK and Ireland. The company aims to be recognised as a dynamic and innovative supplier which operates at the highest levels of professionalism and business integrity.The RoleQuality has always been central in the companys values and this is a key role within the group. You will work with, and be supported by, the top level of management within the company to achieve their strategic goals. The Group Head of Quality will be responsible for multiple sites across the UK, harmonising the Quality Management System across all locations and driving continuous improvement within the quality culture. As Group Quality Manager you will need to be able to juggle managing a team of three whilst also remaining hands-on in the day-to-day quality activities across multiple locations.This new role will suit an experienced and ambitious Quality expert. Prior experience of leading CE and IVDD activities is essential for success, and knowledge of IVDR would be an advantage. Responsibilities include obtaining and maintaining IVDR, CE and UKCA marks for their current and new product portfolios. The role includes the maintenance of individual company quality management systems to ISO 9001:2016, ISO 13485 & ISO 17025 standards, and the establishment of ISO 15189. The Group Head of Quality will also oversee Quality Assurance and Quality Control within their manufacturing sites.Key Skills
  • Relevant industry background in a quality management position
  • Prior experience maintaining a QMS aligned with ISO 13485 and ideally ISO 15189 (or ISO 9001-2016, ISO 17025).
  • Previous experience in attaining CE / UKCA marking.
  • Preparation experience for external audit by regulatory bodies (BSI, UKAS or similar agency).
Key Responsibilities
  • Ensure department targets and objectives are met including post-marketing vigilance, safety, quality, complaint analysis, product conformances.
  • Planning, initiating, and managing quality improvement projects.
  • Experience in conducting internal and external audits.
  • Approval of technical transfers and Quality Agreements.
  • External audits of contractors and suppliers etc. to ensure they comply with site standards.
  • Provide advice and support to the sales, technical, and management teams, and other stakeholders.
  • Monitor quality data daily, and take appropriate action, make decisions, or highlight when necessary.
  • Lead all elements of Quality Control, document control, validation, calibrations, customer Quality interface and supplier Quality Assurance by developing key supplier partnerships.
  • Develop and deliver excellence in manufacturing practices and work with team to develop engagement of all employees in the improvement of Quality, creating training and quality standards to enhance and ensure competence.
  • Management of the Quality Department including annual goal setting, multiskilling, training and management of Quality standards.
  • Any other duty assigned within the skill of the employee.
Essential Criteria
  • A Bachelors degree in Quality / Science / Engineering or other Technical field
  • Manufacturing and distribution experience working in a quality assurance role or related department desired.
  • Must have an understanding of common problem-solving tools
  • Experience in Lean Six Sigma with certification required.
  • Audit qualification or experience
  • Strong leadership and change management skills
Desirable Criteria
  • People management experience.
  • Candidates from a Medical Device background with FDA/ISO or have substantial experience with ISO 9001-2016/13485/15189/17025 will have an advantage.
  • Experience with obtaining/maintaining CE marking/UKCA and IVDR
  • Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions. Proficient at multitasking and prioritizing.
  • Thorough knowledge and understanding of manufacturing systems and solid working knowledge of processes and products.
To ApplyIf you feel you are a suitable candidate and would like to work for this reputable company please do not hesitate in applying.
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Deadline: 23-06-2024

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