Quality Manager

Kelly UK & Ireland
Employment Type
Not disclosed
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Quality Manager

Reports To: Director of Quality and Regulatory CPS
Location: Co. Meath


Responsible for Quality Assurance and managing all resources dedicated to that function. Coordinate Regulatory Affairs for the relevant Europe, Middle East, Africa and Asia (EMEAA) markets.
Main Job Functions:

    • Maintain the quality system in compliance with Annex V, Annex VII and Article 11 of the Medical Device Directive 93/42/EEC, and relevant EMEAA regulations.
    • AsPRRC, under theMDR 2017/745, the Quality Manager is responsible for ensuring that:
      • The conformity of all medical devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
      • The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
      • The post market surveillance obligations are complied, as required
      • All reporting obligations are fulfilled
      • Responsible person for Switzerland and the United Kingdom
    • Ensure that satisfactory standards of quality, sterility, and biological safety are maintained and ensure the Quality System at all times meets ISO 13485 and any other standards which may apply from time to time.
    • Act as Quality System Management representative as outlined in ISO 13485 and any other applicable Quality Management Standard.
    • Ensure Class I and Class IIa products meet all the relevant provisions of the Medical Device Directive 93/42/EEC in relation to CE marking.
    • Ensure that all specifications, processes, materials and products are appropriate for their intent and purpose and in compliance with approved, agreed requirements.
    • Ensure all sampling plans and test methods and procedures are appropriate for their intent and purpose.
    • Ensure that Customers requirements are understood and that all responses to Customers are in a timely manner, are accurate and meet / exceed the customers needs.
    • Identify and prioritise policies and objectives necessary to achieve and maintain quality standards as committed to in the quality policy.
    • Ensure contributions are actively encouraged from quality department for cost improvement and continuous improvement and ensuring all projects and reports are completed in an accurate and timely manner.
    • Inform the Notified Body of any significant changes in systems or procedures which could potentially affect registration.

Job Functions:

    • Comply with the following standard operating procedures:
      • Good Manufacturing Practices
  • (Includes Gowning Requirements in all Production Areas and Hand Hygiene)
      • Good Documentation Practices
      • Facility Security
    • Comply with all standard operating procedures in place relevant to your work activities ensuring not to perform any tasks you have not received training in.
    • Comply with the requirements of the Quality Management System and relevant standards.

Education and Experience:

  • Educated to degree or equivalent level in an Engineering or Scientific Discipline.
  • 3/5 years Quality Assurance, or Microbiology in the Medical Device or Pharmaceutical field.
  • Experience with sterilization systems and validation.

Knowledge and Skills:

  • Be customer focused in an ever changing dynamic marketplace.
  • Ability to analyse information, draw conclusions and make sound and timely decisions.
  • Ability to deal with ambiguity, rapidly prioritise and respond to change quickly.
  • A passion for continually improving processes with a focus on results.
  • Financially astute and bottom line driven with a good aptitude for numbers.
  • Demonstrated people management skill, a strong team builder with good strategic perspective who possesses strong influencing and communication skills

Key Competences:

  • Must have a flexible approach to work and be capable of handling multiple priorities in a fast-paced environment.
  • Strong attention to detail with a high degree of accuracy and excellent organisational and communication skills.
  • Ability to work with and empathize with colleagues and customers from varied backgrounds and cultures.

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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.