Quality Specialist

Life Science Recruitment; Eu; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading recruitment agency is seeking a Quality Assurance Specialist to support the development and implementation of a Quality Management System for a Medical Device client. The role involves ensuring compliance with 2017/745(MDR), ISO 13485, and FDA QSR standards. Ideal candidates will have at least 3 years of experience in quality within a highly regulated industry and a third-level qualification in natural sciences.

Prestations

Good salary

Healthcare

Pension

25 days holidays

Career growth opportunities

Qualifications

• 3+ years’ experience in Quality and Good Documentation Practices in a highly regulated industry.

Responsabilités

• Aid the team in the development implementation and maintenance of the Quality Management System.
• Support the operation of the Quality Management System & Documentation control.
• Perform Internal Audits or Supplier audits.
• Drive continuous improvement initiatives within the QMS.

Connaissances

Good communication (oral and written)

Good planning and organizational skills

Attention to detail

Formation

Third level qualification in natural sciences

Description du poste

Job title: Quality Assurance Specialist
Location: Western Business Park, Shannon, Co. Clare
Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept.

Summary:
The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development, Manufacturing including secondary packaging activities and Distribution.

Responsibilities:

• Aid the team in the development implementation and maintenance of the Quality Management System.
• Support the operation of the Quality Management System & Documentation control such as:
  • Change Controls, CAPAs and Non conformances, Training, Internal, vendor and third party audits, participate in product and process risk assessments.
  • Perform Internal Audits or Supplier audits.
  • Perform Supplier Qualification & monitoring as requested.
  • Drive continuous improvement initiatives within the QMS.
  • Partake in Customer specific or internal quality projects.
  • Perform QA Verification of activities performed in production.
  • Review and update Quality System documentation (procedures, Reports) as requested.
  • Partake in activities for design & process validation.
  • Take part in Notified Body Audits and Audit preparation as requested. Generate Quality Metric reports as required and assist in any other data compilation as requested.

Requirements:

• Qualifications: Third level qualification in natural sciences (Certificate, Diploma, Degree level).
• 3+ years’ experience in Quality and Good Documentation Practices in a highly regulated industry (pharma, medical devices).
• Good planning and organizational skills.
• Good communication (oral and written).
• Hardworking and highly motivating individual, with good attention to detail.