Medical Device Validation Specialist

20 hours ago

Sligo, Sligo, Ireland beBeeValidation Full time €57,000 - €78,000

Job Overview

The Quality Assurance Validation Engineer plays a pivotal role in ensuring the quality and compliance of medical devices at a manufacturing site. If you have experience in Quality / Validation engineering and enjoy working collaboratively with a diverse team, we encourage you to apply.

Key Responsibilities:

  • Coordinate and participate in validation and quality assurance activities for site equipment, utilities, processes, and software in compliance with regulatory standards.
  • Develop and maintain Site Validation Master Plans, Project Validation Plans, and schedules to ensure efficient execution.
  • Generate validation protocols, final reports, and investigations to regulatory standards.
  • Create, review, and approve various quality documents and test data.
  • Maintain validation, exception event, and change control processes to ensure seamless operations.
  • Track and maintain validation equipment as required.
  • Complete necessary training before executing tasks and document activities according to regulatory requirements.
  • Update validation procedures, job instructions, and batch documentation to reflect current best practices.
  • Perform cross-training within the team and train new members to enhance skills and knowledge.
  • Participate in continuous improvement programs to implement improvements in manufacturing, quality, safety, and training systems.
  • C coordinate activities to maximize team effectiveness and maintain overall regulatory compliance of production areas.
  • Communicate with peers and management regarding activities, including elevating events or concerns.

Required Skills and Qualifications:

  • Degree in an engineering or scientific discipline.
  • 3+ years of validation/Quality experience in medical device plastics processing, moulding, or assembly operations.
  • 3+ years of knowledge of regulatory requirements relating to the medical device industry.

  • Medical Device Validation Specialist

    1 week ago

    Sligo, Sligo, Ireland beBeeValidation Full time €60,000 - €85,000

    About This RoleThis position oversees the validation program to guarantee conformity with regulatory requirements, quality standards and industry guidelines.Manage site equipment, utilities, processes and software validation to ensure compliance.Develop and maintain a validation master plan, project plans and schedules.Prepare and submit validation protocols...

  • Medical Device Validation Specialist

    6 days ago

    Sligo, Sligo, Ireland beBeeValidation Full time €60,000 - €87,000

    Job Opportunity:We are seeking a highly skilled QA Validation Engineer to coordinate and implement our site validation program, ensuring compliance with regulatory requirements.This role involves overseeing validation activities for equipment, utilities, processes, and software, as well as participating in Quality Assurance initiatives that drive business...

  • Validation and Quality Assurance Specialist

    1 week ago

    Sligo, Sligo, Ireland beBeePharmaceutical Full time €60,000 - €80,000

    Pharmaceutical Engineer Role in West IrelandLocated on the picturesque west coast of Ireland, our pharmaceutical client is seeking a skilled Pharmaceutical Engineer to join their state-of-the-art facility.The successful candidate will be responsible for coordinating and participating in the validation and quality assurance of site equipment, utilities,...

  • Validation Specialist

    15 hours ago

    Sligo, Sligo, Ireland beBeevalidation Full time €90,208 - €108,369

    Job Description:We are seeking a highly skilled Validation Specialist to join our team. The successful candidate will be responsible for coordinating and participating in the validation of site equipment, utilities, processes, and software to ensure compliance with regulatory standards. This is an excellent opportunity to work in a dynamic environment and...

  • Innovative Medical Devices Specialist

    4 days ago

    Sligo, Sligo, Ireland beBeeClinicalResearch Full time €60,000 - €90,000

    Senior Clinical Research Associate Job DescriptionWe are seeking a skilled Senior Clinical Research Associate to manage clinical study activities as part of our clinical team. This is an excellent opportunity to support the development of innovative medical devices in line with ISO standards, FDA regulations, and EU MDR.Key Responsibilities:Coordinate...

  • Medical Devices Development Specialist

    3 days ago

    Sligo, Sligo, Ireland beBeeClinicalResearchAssociate Full time €80,000 - €110,000

    Our company is seeking a Senior Clinical Research Associate to manage clinical trials outsourced to CRO's and support the development of innovative medical devices in line with ISO standards, FDA regulations, EU MDR, and other applicable requirements.Key Responsibilities:Coordinate clinical investigation activitiesWork with site staff, consultants, and teams...

  • Medical Device Clinical Trials Specialist

    2 weeks ago

    Sligo, Sligo, Ireland beBeeClinicalResearch Full time €60,000 - €95,000

    Clinical Research Associate OpportunityOur company is seeking a highly skilled Clinical Research Associate to join our team and contribute to the success of our clinical trials. This individual will be responsible for managing clinical study activities as part of the clinical team, supporting the development of innovative medical devices in line with ISO...

  • Senior Quality Assurance Specialist

    2 days ago

    Sligo, Sligo, Ireland beBeeValidation Full time €55,000 - €85,000

    Job Title: QA Validation EngineerWe are seeking a highly skilled professional to coordinate the development and maintenance of our site validation program. As a key member of our team, you will be responsible for ensuring that our processes and systems meet the highest standards of quality and regulatory compliance.Main Responsibilities:Coordinate and...

  • Medical Device Innovator

    1 week ago

    Sligo, Sligo, Ireland beBeeDesign Full time €60,000 - €70,000

    Product Design SpecialistWe are seeking a seasoned product design specialist to join our team at Collins McNicholas Recruitment, exclusively partnering with Arrotek.The ideal candidate will possess a strong background in medical device design and development, with expertise in product innovation, quality assurance, and regulatory compliance.Key...

  • Senior Validation Specialist

    7 days ago

    Sligo, Sligo, Ireland beBeeValidation Full time €50,000 - €80,000

    The role of a Senior Validation Specialist involves overseeing and implementing site validation programs to ensure compliance with external regulatory requirements and industry best practices.Key ResponsibilitiesCoordinate, direct, and actively participate in validation activities for site equipment, utilities, processes, and software.Ensure compliance with...