Quality System Engineer

4 weeks ago


Dublin, Dublin City, Ireland Cpl Full time

Quality Systems Engineer

This role supports the Quality Systems Manager and will include implementing & maintaining the Quality Management System in accordance with applicable standards and regulations.

Responsibilities:

  • Be a key driver of cGMP practices within Quality and Operations
  • Be the primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.
  • Ensure adherence to internal and external regulatory requirements
  • Be an active member of the internal audit team and support external audits at the site
  • Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA
  • Prepare and present data to management on quality system performance
  • Drive thorough investigation & root cause analysis of CAPAs and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence
  • Support other Quality processes and implement improvement activities
  • Provide a quality review on a range of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation as required

Educational Requirements:

  • A primary degree in a Science/Engineering discipline

Relevant Experience:

  • A minimum of 5 years work experience in the Medical Devices Pharmaceutical regulated environment working within an established Quality System
  • Proven experience leading CAPAs and Internal Audits
  • Strong problem solving ability
  • Experienced in technical writing and review with good attention to detail
  • Proven ability of working on own initiative and in a cross-functional team environment
  • Excellent interpersonal and communication skills
  • Ability to prepare and present data effectively
  • Qualified Internal Auditor experience


  • Dublin, Dublin City, Ireland Cpl Full time

    On behalf of my client, a global pharmaceutical company with offices in Dublin, we are collaborating with them on a new vacancy for a Quality System Specialist (Deviations and CAPAs) The primary purpose of this position is the management of the Quality System functions in the organisation in relation to Deviations and CAPAs. This role will also support with...


  • Dublin, Dublin City, Ireland Cpl Full time

    Responsibilities• Maintain the document management system as required including management of templates, allocation of document numbers and review of draft documents.• Administrate documents on the document management system acting as the primary document coordinator.• Provide support to users of the document management system.• Act as the primary...

  • Quality Engineer

    4 weeks ago


    Dublin, Dublin City, Ireland CPL Healthcare Full time

    Quality Engineer Permanent Engineering manufacturing This is a dream job for anyone that has an interest in heavy engineering or Agri related machinery. This is a hidden gem that manufacture and supply with a large global market and the site is commutable from Cavan, Meath and parts of Westmeath.The primary function of the role is to provide Quality...

  • System Engineer

    1 week ago


    Dublin, Dublin City, Ireland Concat AG Full time

    System Engineer (m/w/d) 3rd Level - mobiles Arbeiten Starte mit deinem Team und der gesamten Concat als Community deinen Arbeitsalltag bei uns. Die Concat hat sich seit ihrer Gründung zu einem international agierenden Unternehmen entwickelt. Ein vielseitiges Aufgabengebiet und eine familiär geprägte Atmosphäre warten auf dich. Wir fördern und...


  • Dublin, Dublin City, Ireland Cpl Full time

    Senior Performance Quality Engineer· Dublin – Hybrid· Long Term Contract· Negotiable Day RateGlobal Financial Services / Investment Organisation is looking a Senior Performance Quality Engineer to join their team on a long term rolling contract. The role will be reporting to the Team Lead of the Performance Automation & Testing Team, you will be...


  • Dublin, Dublin City, Ireland Allegion Canada Inc. Full time

    Supplier Quality Engineer (Electronics) page is loaded Supplier Quality Engineer (Electronics) Apply locations Remote, Mexico time type Full time posted on Posted Yesterday job requisition id JR28426 Creating Peace of Mind by Pioneering Safety and Security At Allegion, we help keep the people you know and love safe and secure where they live, work and...


  • Dublin, Dublin City, Ireland Reperio Human Capital Full time

    Big Data Systems Engineer Location: Dublin Duration: Initial 12 Month (potential to extend further) A new opportunity has opened up for a Senor Big Data Systems Engineer to join my global client, based in Dublin, Ireland. This is an initial 1 year contract with great potential to extend. My client are looking for a strong data engineer to join the team to...


  • Dublin, Dublin City, Ireland GrabJobs Full time

    Job summaryAssociate Manager Quality Compliance position Facilitating activities and relationships regarding External Manufacturing change controls Lead and manage direct reports, work to develop and oversee their performance and growth Job seniority: mid-to-senior level Responsibilities Meeting with External Manufacturing department to discuss changes for...

  • Quality Technician

    4 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    On behalf of our client, we currently have an excellent opportunity for a Quality Technician to join a growing Medical Technology company. Dublin location, predominately site based with some hybrid.The Quality Technician will work closely with colleagues to support the following activities:· Creation, review, and approval of QMS documentation.· Process and...


  • Dublin, Dublin City, Ireland Amazon Full time

    Amazon Development Centre Ireland Limited - D94Amazon's network is crucial for Amazon Cloud Computing and Amazon Web Services (AWS). The Networking team is responsible for developing and operating this network, which is known for its efficiency, throughput, and reliability, playing a vital role for AWS customers worldwide.The team is currently seeking a...


  • Dublin, Dublin City, Ireland Cpl Full time

    On behalf of my client, a global pharmaceutical company, we are working with them on a new role for a Pharmacovigilance and Clinical Quality Specialist. This is a full-time permanent role based in Dublin. The Role & Responsibilities: The main purpose of this cross functional position is coordinating and leading a variety of: Pharmacovigilance system quality...

  • Quality Manager

    3 weeks ago


    Dublin, Dublin City, Ireland GrabJobs Full time

    We are searching for an experienced Quality Manager to join our all-star team at North Cork Creameries in Cork.Growing your career as a Full Time Quality Manager is an incredible opportunity to develop competitive skills.If you are strong in persuasion, teamwork and have the right experience for the job, then apply for the position of Quality Manager at...

  • Quality Auditor

    4 weeks ago


    Dublin, Dublin City, Ireland GCL Group Full time

    GCL Group are currently seeking an experienced Quality Auditor for their client, a Top Contractor with a large portfolio of work in the Leinster area. Responsibilities: Conduct QA/QC site inspections across multiple sites in the greater Dublin area. Monitor overall construction performance with regard to technical quality and compliance with design and...


  • Dublin, Dublin City, Ireland Pfizer Full time

    Quality Operations Manager page is loaded Quality Operations Manager Bewerben locations Ireland - Dublin - Ringsend time type Vollzeit posted on Vor 3 Tagen ausgeschrieben job requisition id Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to...


  • Dublin, Dublin City, Ireland Siemens Full time

    Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow...

  • Mechanical Engineer

    4 weeks ago


    Dublin, Dublin City, Ireland EXEC Search Full time

    Role: Mechanical Engineer As a Mechanical Engineer, you will be responsible for designing, analyzing, and improving various mechanical systems and components. You will work closely with our client's engineering team to ensure that the products meet the highest quality and safety standards. Responsibilities:Design and develop mechanical systems and components...


  • Dublin, Dublin City, Ireland icon Full time

    Mexico City, Sofia, Dublin, Warsaw, BucharestAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...

  • MES Engineer

    24 hours ago


    Dublin, Dublin City, Ireland Cpl Full time

    The MES Engineer will be responsible for developing reliable and robust MES system and master recipes to meet process requirements to ensure appropriate MES content and changes to meet the facility goals of High Product Quality and Lean Manufacturing.Responsibilities· Performing MES recipe authoring activities to ensure appropriate MES content and changes...

  • Project Engineer

    1 week ago


    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with SK biotek are looking for a Project Engineer to join their team for a 12 month contract.Position Title: Project EngineerLocation: SK biotek Ireland, Watery Lane, Swords, Co. DublinOverview:We have a number of in-house projects to be implemented over the next 12 months. An internal team will manage the projects from conception to...

  • Process Engineer

    1 week ago


    Dublin, Dublin City, Ireland Arcon Recruitment Services Full time

    Process engineer required for client in Ballina Co.Mayo Apply a proactive and methodical approach to troubleshooting daily shift operation issues and continuous improvement with cross functional teams, comprised of operations shift managers, technicians, engineers, quality, and safety. Perform detailed, technical breakdown analysis of improvements (losses...