Quality Manager

Quality Manager

The Role:

 On behalf of my client a global medical devices company, we are now recruiting for a Quality Manager to join the team.   Reporting to the Director of Quality and Regulatory you will be responsible for Quality Assurance and managing all resources dedicated to that function.  Hybrid working opportunity.  FTC

Key Responsibilities:

Coordinate Regulatory Affairs for the relevant Europe, Middle East, Africa, and Asia (EMEAA) markets.

• 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. As PRRC, under the MDR 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 always 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.

EDUCATION & EXPERIENCE REQUIRED: 

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.

 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.

For full job spec and details email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701 Thornshaw Scientific is a division of the CPL Group www.thornshaw.com