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Quality Engineer

1 month ago

Galway, Galway, Ireland Barrington James Full time

About this Job:

As part of the Quality team, the Quality Systems Engineer will support the implementation and ongoing development of the company's Quality Management System (QMS), helping ensure compliance with global medical device regulations and quality standards.

Job Responsibilities:

  • Coordinating and maintaining the CAPA and complaints handling system, including assessment, investigation oversight, and closure approval.
  • Leading the company's audit readiness — managing internal and external audit schedules, coordinating audit activities, and tracking findings to resolution.
  • Supporting software lifecycle validation activities to maintain a compliant and validated electronic quality system.
  • Overseeing supplier management activities such as qualification, ongoing performance monitoring, and documentation control.
  • Managing the process for Temporary Authorisation requests, ensuring clear tracking and resolution.
  • Facilitating monthly and quarterly QMS reporting and providing data insights for Management Review and other leadership updates.
  • Acting as a quality liaison across departments, helping to integrate compliance oversight into cross-functional projects and routine activities.
  • Conducting compliance assessments and gap analyses against applicable regulatory frameworks (e.g., MDR 2017/745, FDA QSR, ISO 13485, ISO 14971, Japanese).
  • Escalating delays in quality system actions, supporting resolution plans, and collaborating with leadership on risk mitigation strategies.
  • Driving ongoing quality improvement efforts within the QMS, contributing to both operational excellence and regulatory readiness.
  • Providing backup support for document control processes and contributing to broader quality-related initiatives and submissions.

Candidate Profile

We're looking for a proactive and detail-oriented individual with experience in regulated environments and a solid foundation in Quality Assurance.

Skills and Experience:

  • Minimum two years of experience in a regulated industry, preferably medical devices or pharmaceuticals.
  • Solid understanding of ISO standards and global medical device regulatory frameworks (ISO 13485, ISO 14971, MDR, FDA 21 CFR Part 820).
  • Background in managing QMS processes such as complaint handling, audit coordination, software validation, or supplier oversight.
  • Clear communicator with strong documentation and organisational skills.
  • Comfortable working in a cross-functional environment with multiple concurrent priorities.
  • Diploma (or higher) in Engineering, Life Sciences, or a Quality-related discipline.

Why Apply

  • Be part of a purpose-driven organisation focused on innovation and quality.
  • Work in a modern facility with a collaborative and supportive team culture.

Enjoy a range of attractive benefits including:

  • Competitive salary and bonus structure
  • Pension scheme with enhanced employer contributions
  • Private medical coverage for employee and dependents
  • 23 days annual leave (plus public holidays), increasing with tenure
  • Paid sick leave and group life insurance

If joining a progressive Medical Device company is an interest for you feel free to reach out:

lcattcamfield@barringtonjames.com

+44 (0) 1293 776644

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