Quality Engineer

6 days ago


Galway, Ireland Cregg Full time

Galway's world leading medical device manufacturing company have available opportunities for EXPERIENCED Manufacturing Engineers to join their team.
Please send CV to ****** or call 0860127415 to apply.
About the role
Purpose:
To support a critical site-wide remediation program following an FDA 483 observation.
This role offers a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to drive compliance improvements and process validation initiatives.
Hours of work:
Monday-Friday 39hr week with a 1pm Friday finish.
Hybrid role offering 2 days work from home.
Key Responsibilities
Partner with manufacturing process owners to identify and remediate compliance gaps.
Support manufacturing process validation activities (IQ/OQ/PQ).
Update quality system documentation and technical files to ensure audit readiness.
Drive closure of CAPAs and NCRs with effective corrective actions.
Provide clear and concise technical writing for quality and manufacturing procedures.
Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.
Qualifications & Experience
Bachelor's degree in Engineering or Quality-related discipline.
2–5 years of experience in medical device manufacturing, quality, or remediation projects.
Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
Proven technical writing and documentation skills.
Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.
Excellent problem-solving skills with the ability to take a problem statement through to a compliant solution.
#J-18808-Ljbffr


  • Quality Engineer

    3 weeks ago


    Galway, Galway, Ireland Team Horizon Full time

    Team Horizon is seeking a Quality Engineerto join our clients Engineering team at a GMP-regulated biopharmaceutical facility in Ireland.This role supports 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 Engineering and Quality...

  • Quality Engineer

    3 weeks ago


    Galway, Ireland Cregg Group Full time

    Quality Engineer East Galway Permanent This role would suit an experienced hands-on Quality Engineer or Supervisor that has a strong ability to work on their own initiative and is looking for long term career growth.A Quality Manager that is looking for a new challenge will also be considered.This job will be ideal for someone working in an Industrial...

  • Quality Engineer

    3 weeks ago


    Galway, Ireland Cregg Full time

    Quality EngineerEast GalwayPermanentThis role would suit an experienced hands-on Quality Engineer or Supervisor that has a strong ability to work on their own initiative and is looking for long term career growth.A Quality Manager that is looking for a new challenge will also be considered.This job will be ideal for someone workingin an Industrial...

  • Quality Engineer

    1 week ago


    Galway, Ireland Cregg Full time

    Quality Engineer - GalwayCREGG Recruitment are hiring for a Quality Engineer to join a leading Medical Device company in Galway.For more information contact Mark: (emailprotected) orAbout the RoleWe are seeking a highly motivatedQuality Engineerto join our world-class medical device team in Galway.This is an exciting opportunity to contribute to the...

  • Quality Engineer

    4 days ago


    Galway, Ireland Cregg Full time

    Quality Engineer - GalwayCREGG Recruitment are hiring for a Quality Engineer to join a leading Medical Device company in Galway.For more information contact Mark: [emailprotected] or 0861901346About the RoleWe are seeking a highly motivatedQuality Engineerto join our world-class medical device team in Galway.This is an exciting opportunity to contribute to...

  • Quality Engineer

    3 weeks ago


    Galway, Galway, Ireland Bluedrop Medical Full time

    Job Title: Senior Quality EngineerLocation: Galway, Ireland (Hybrid)Department: OperationsReports to: VP of OperationsType: Full-time, PermanentAbout Bluedrop MedicalBluedrop Medical is a fast-growing medtech company developing sensor-based technology to prevent diabetic foot ulcers—a leading cause of amputation worldwide. Our advanced imaging and sensor...

  • Quality Engineer

    4 weeks ago


    Galway, Galway, Ireland Oxford Global Resources Full time

    Are you a Quality/Manufacturing engineer looking for a new opportunity? Don't hesitate and apply todayPROJECT DESCRIPTIONWe are seeking experienced Remediation Quality Engineers / Manufacturing Engineers to support a site-wide remediation program following an FDA 483. These roles will focus on manufacturing process validation, quality system updates, and...

  • Quality Engineer

    4 weeks ago


    Galway, Galway, Ireland Reperio Human Capital Ltd Full time

    Quality Engineer - Contract I'm looking for a proactive individual to work with my reputable client on an upcoming project on a daily rate contract basis.This role will initially be for 6 months but will like offer further extension.Its an excellent opportunity for an experienced quality engineer who is looking for their next role and can support an existing...

  • Quality Engineer

    4 weeks ago


    Galway, Galway, Ireland TE Connectivity Corporation Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Select how often (in days) to receive an alert:At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.Job OverviewReporting to the Quality Manager/Quality Supervisor, the...

  • Quality Engineer

    3 weeks ago


    Galway, Ireland Oxford Global Resources Full time

    Are you interested in taking the next step in your career with a global leader in the medical device industry?Are you ready to challenge yourself in a fast-paced and high-regulated environment?Are you an experienced quality or manufacturing engineer with a background in process validation and/or CAPA implementation?You could be the perfect candidate for this...