Senior Quality Engineer

Jobleads (Limerick, Ireland) 5 days ago

Location: Limerick

Job Overview: A leading provider of healthcare products is now looking to hire a Senior Quality Engineer. The primary role is to drive compliance and continuous improvement of the site Quality Management System to required Quality & Regulatory standards.

Reporting to: Quality & Operations Manager

Role Responsibilities:

  • Drive compliance to key related QMS activities such as New Product Introduction, Supplier Quality, Change control, Complaints, NC & CAPA
  • Monitor and drive improvements to Key Performance Indicators (KPIs)
  • Management of Documentation control within QMS System
  • Drive improvements to QMS documents and systems
  • Coordinate Internal Audit system and Audit Team activities to required schedule
  • Drive Quality requirements related to New Product Introduction, continuously assessing regulatory impact on new product releases or product updates in adherence to MDR
  • Maintain appropriate product records to demonstrate compliance with applicable quality standards and regulations, ISO13485, MDD 93/42/EEC, MDR 2017/745
  • Identify and implement operational improvement initiatives
  • Development of appropriate trending analysis and sampling plan reviews
  • Prepare for and participate in external regulatory inspections
  • Other projects or duties as assigned by Manager

Required Skills & Competencies:
  • Good knowledge of Quality Assurance and Regulatory Standards
  • Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form
  • Attention to detail and accuracy to deal effectively with literature and data reviews
  • Self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements
  • Good technical writing skills and experience
  • Good computer skills including knowledge of Microsoft®, ERP and QMS database systems
  • Demonstrates behaviours in line with company core values and ethics standards

Desired  Qualifications & Experience:
  • Third level qualification in related discipline
  • Minimum 4 years’ experience in a similar role
  • Experience of working in a similar Quality Assurance related role in the Medical Device Industry is an advantage
Job Type: Full-time, Permanent

Salary: Negotiable

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Senior Quality Engineer

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