Quality Engineer

4 weeks ago

Galway, Galway, Ireland Guided Solutions Full time

For our client, a leading global medical device manufacturer, we are seeking a Quality Engineer to join a dynamic New Product Development site in Galway, Ireland. This is a unique opportunity to play a pivotal role in the development and production of innovative medical devices.

This is a multi-functional, hands-on role, ideal for someone who thrives in a dynamic environment where responsibilities span across the Quality Management System (QMS), elements of Quality Control (QC), and cross-functional engineering support. Given the lean nature of the site, the successful candidate will be a key contributor across various quality and operational areas.

Please note that the role requires daily on-site presence.

Key Responsibilities:

  • Oversee and support daily quality activities on the production floor
  • Maintain and improve the Quality Management System (QMS) in line with ISO 13485
  • Conduct internal audits and identify areas for improvement
  • Lead investigations, root cause analysis, and implement CAPAs
  • Review and approve DHRs, validation protocols, and change controls
  • Support risk assessments and product risk management activities
  • Manage supplier quality and conduct supplier audits
  • Train and support teams on quality standards and best practices
  • Monitor key quality metrics and report performance
  • Ensure quality is integrated throughout product development
  • Support audit readiness and regulatory inspections

Requirements:

  • Proven experience in quality engineering in a medical device manufacturing environment
  • Experience working with Quality Management Systems (QMS) and standards such as ISO 13485 and FDA regulations
  • Strong understanding of quality control principles, statistical analysis, and root cause analysis techniques
  • Experience with internal and external audits
  • Experience working in small or fast-paced environments
  • Strong hands-on experience with V&V
  • Ability to work independently and take ownership of quality processes
  • Skilled in coaching and guiding production teams
  • Excellent documentation and communication skills
  • Flexible, hands-on, practical, and comfortable with cross-functional tasks
#J-18808-Ljbffr

  • Quality Engineer

    2 days ago

    Galway, Galway, Ireland Cpl Healthcare Full time

    JO-2507-555094Our client - a GMP-regulated biopharmaceutical facility in Sligo, requires a Quality Engineering to join their engineering team. The successful candidate will support engineering projects and day-to-day operations with a strong focus on compliance, validation, and quality risk management. The Quality Engineer acts as a key interface between...

  • Quality Engineer

    4 days ago

    Galway, Galway, Ireland Global Professional Consultants Full time

    Quality Engineer Quality Engineer required for a Tier 2 Main Building Contractor to work on a healthcare project in Galway The successful Quality Engineer will be a key part of the project management team and have worked previously on a similar type of role in Ireland or the UK previously. We will also consider traditional senior engineering candidates that...

  • Quality Engineer

    1 week ago

    Galway, Galway, Ireland MBRYONICS Full time

    Mbryonics is at the forefront of free space optical communications. Our product portfolio covers a wide range of emerging technologies from photonic integrated circuits to advanced optical systems and embedded software solutions. Our optical communications systems are integrated and deployed in satellite communications systems. The work is exciting and...

  • Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland GxP Recruitment Full time

    We are working on an exciting Quality Engineer role for a large medical device client in Galway.Note: no sponsorship is provided for this contract position, a valid working visa is required.• Works on projects associated with line moves, equipment updates, CAPAs etc• Has the responsibility and independent authority to make decisions related to product...

  • Quality Engineer

    2 days ago

    Galway, Galway, Ireland MBRYONICS Full time

    Join to apply for the Quality Engineer role at MBRYONICSJoin to apply for the Quality Engineer role at MBRYONICSGet AI-powered advice on this job and more exclusive features.Mbryonics is at the forefront of free space optical communications. Our product portfolio covers a wide range of emerging technologies from photonic integrated circuits to advanced...

  • Quality Engineer

    1 week ago

    Galway, Galway, Ireland SRG Full time

    Join a Leading Innovator in Medical Device Development as a Design Quality Assurance EngineerAre you ready to take your career to the next level in a dynamic, collaborative, and forward-thinking environment? This is your opportunity to contribute to life-changing medical technologies while growing professionally in a supportive and inclusive workplace.Why...

  • Senior Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland Cpl Healthcare Full time

    Senior Quality EngineerMy client, a mayo based manufacturing company that specialises in metal products for the medical device industry is looking to recruit a Senior Quality Engineer for their Castlebar site. The successful candidate will work on a team of 5 quality professionals and report to the Quality Manager.Responsibilities:Ensure compliance with...

  • Senior Quality Engineer

    2 weeks ago

    Galway, Galway, Ireland Accpro Full time

    Duties: Support sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards. Support the introduction/implementation of product/process/materials changes to the manufacturing operation. You...

  • CMM Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland MBRYONICS Full time

    Mbryonics is at the forefront of free space optical communications. Our product portfolio covers a wide range of emerging technologies from photonic integrated circuits to advanced optical systems and embedded software solutions. Our optical communications systems are integrated and deployed in satellite communications systems. The work is exciting and...

  • Senior Quality Engineer

    6 days ago

    Galway, Galway, Ireland Accpro Full time

    Duties: Support sustaining commercial projects from a Design Assurance perspective.You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards.Support the introduction/implementation of product/process/materials changes to the manufacturing operation.You will...