Current jobs related to Medical Device Quality Assurance Specialist - Galway, Galway - Quasar Medical | Medical Device Manufacturer

  • Medical Device Quality Assurance Specialist

    3 days ago

    Galway, Galway, Ireland Life Science Recruitment Full time

    Job Title: Medical Device Quality Assurance Specialist About the Role:We are seeking a detail-oriented Medical Device Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.Key...

  • Medical Device Quality Assurance Specialist

    3 days ago

    Galway, Galway, Ireland TN Ireland Remote Work Freelance Full time

    About the Role:The ideal candidate will be responsible for leading quality assurance activities on medical device projects, ensuring compliance with relevant regulations and industry standards.Key Responsibilities:Develop and implement quality plans to ensure product safety and effectiveness.Collaborate with cross-functional teams to identify and mitigate...

  • Quality Assurance Specialist

    4 days ago

    Galway, Galway, Ireland Life Science Recruitment Full time

    About the Role:">">This Design Assurance Program Manager position involves leading quality representatives on projects, ensuring the establishment of Design History Files and Device Master Records.">You will be responsible for implementing Nordson Medical Quality Systems across projects, adhering to relevant regulations and industry standards.">Investigating...

  • Medical Device Quality Assurance Specialist

    2 days ago

    Galway, Galway, Ireland TN Ireland Remote Work Freelance Full time

    About the PositionWe are seeking a highly skilled and experienced Quality Assurance Project Lead to join our team at Nordson Medical in Galway, Ireland. The successful candidate will be responsible for leading quality assurance efforts, managing customer relationships, and collaborating with cross-functional teams.The ideal candidate will have a minimum of...

  • Quality Assurance Director

    3 days ago

    Galway, Galway, Ireland Nordson Corporation Remote Work Freelance Full time

    Required Skills and QualificationsTo be successful in this role, you will need:A minimum Bachelor's degree in Engineering or a related field.10 years of medical device design and development/quality assurance experience.Demonstrated ability to lead product verification & validation activities.Familiarity with FDA QSRs, medical device regulations, and ISO...

  • Medical Device Quality Assurance Specialist

    3 days ago

    Galway, Galway, Ireland Life Science Recruitment Ltd Full time

    Company OverviewLife Science Recruitment Ltd is a global leader in the medical device industry, expert in the design, development, and manufacturing of complex medical devices and component technologies.Salary InformationThis part-time position offers an hourly rate contract with 3 days of work per week. The company also offers hybrid working...

  • Quality Assurance Technician

    1 day ago

    Galway, Galway, Ireland HERO Recruitment Full time

    We are seeking a highly motivated Quality Assurance Technician - Medical Devices to join our client's Operations Team in Galway.This role involves optimizing production performance, improving processes, and ensuring top-quality standards in a fast-paced medical device manufacturing environment.Main Accountabilities:Monitor and maintain line performance to...

  • Quality Assurance Specialist

    2 days ago

    Galway, Galway, Ireland Life Science Recruitment Ltd Full time

    Job Title: Quality Assurance SpecialistThe ideal candidate for this Quality Assurance Specialist role will have a strong background in quality engineering within the medical device industry. As a key member of our team, you will be responsible for ensuring product quality during early development phases through to commercialization.Key Responsibilities:-...

  • Design Quality Manager

    6 days ago

    Galway, Galway, Ireland Life Science Recruitment Full time

    Job Description: Quality Assurance Specialist - DesignKey Responsibilities:Establish and maintain Design History Files and Device Master Records for medical devices.Develop and implement quality plans for new product introductions.Collaborate with cross-functional teams to ensure design controls are met.Investigate and resolve quality-related issues.Maintain...

  • Quality Assurance Specialist

    2 days ago

    Galway, Galway, Ireland Life Science Recruitment Ltd Full time

    Role Summary: We are seeking an experienced Quality Assurance Specialist to join our team as a Design Assurance specialist. The successful candidate will have a strong background in quality assurance and regulatory affairs, with experience working in the medical device industry.In this role, you will be responsible for ensuring that all design activities...

  • Medical Device Quality Assurance Manager

    3 days ago

    Galway, Galway, Ireland Nordson Corporation Remote Work Freelance Full time

    About the RoleWe are looking for a seasoned Project Manager with expertise in medical device design and development/quality assurance to lead our quality assurance efforts. You will be responsible for ensuring product quality, safety, and effectiveness by leading quality representative teams on projects.Develop and implement quality systems and processes to...

  • Design Quality Assurance Specialist

    2 days ago

    Galway, Galway, Ireland Nordsonmedical Remote Work Freelance Full time

    Job SummaryNordson Medical is looking for a highly experienced Design Quality Assurance Specialist to join our team. The successful candidate will have a strong background in medical device development and quality assurance.Main Responsibilities:Develop and implement quality assurance strategies to ensure compliance with regulatory requirements.Collaborate...

  • Medical Device Quality Lead

    6 days ago

    Galway, Galway, Ireland Life Science Recruitment Full time

    Job SummaryWe are looking for an experienced Medical Device Quality Lead to join our team at Life Science Recruitment. As a key member of our organization, you will be responsible for leading the quality assurance agenda across the company, ensuring compliance with regulatory requirements, and maintaining a certified Quality Management System.About the...

  • Senior Quality Assurance Specialist

    3 days ago

    Galway, Galway, Ireland Life Science Recruitment Full time

    Job Title: Senior Quality Assurance SpecialistImplement and promote best-in-class quality assurance through the product lifecycle for my client device.About the Role:This is an excellent opportunity to lead and develop a high-performing quality team, driving continuous improvement and innovation in quality systems. As a Senior Quality Assurance Specialist,...

  • Quality Assurance Specialist

    3 days ago

    Galway, Galway, Ireland TN Ireland Full time

    We are looking for a Quality Assurance Specialist to join our team at TN Ireland. As a Quality Assurance Specialist, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance.About the Role:In this role, you will be responsible for investigating field complaints, sourcing and ordering...

  • Quality Assurance Specialist

    6 days ago

    Galway, Galway, Ireland Life Science Recruitment Full time

    Job OverviewWe are seeking a highly experienced and skilled Quality Assurance Specialist to join our team at Life Science Recruitment. As a key member of our organization, you will be responsible for leading the quality assurance agenda across the company, ensuring compliance with regulatory requirements, and maintaining a certified Quality Management...

  • Medical Device Optimization Specialist

    1 day ago

    Galway, Galway, Ireland HERO Recruitment Full time

    At HERO Recruitment, we are seeking a highly skilled Medical Device Optimization Specialist to join our client's Operations Team in Galway.This hands-on role involves optimizing production performance, improving processes, and ensuring top-quality standards in a fast-paced medical device manufacturing environment.Main Responsibilities:Monitor and maintain...

  • Medical Device Quality Manager

    2 days ago

    Galway, Galway, Ireland Life Science Recruitment Ltd Full time

    Life Science Recruitment Ltd is seeking an experienced Medical Device Quality Manager to join their dynamic team.This role will be responsible for leading quality personnel, supervising quality technicians, and managing quality aspects of internal manufacturing and sub-contract manufacturing partners.The successful candidate will possess exceptional...

  • Medical Device Quality Lead

    7 days ago

    Galway, Galway, Ireland Life Science Recruitment Ltd Full time

    Quality Assurance RoleWe are seeking a highly skilled Quality Manager to join our team at Life Science Recruitment Ltd. The successful candidate will be responsible for ensuring the highest standards of quality in our medical device development and manufacturing processes.The Quality Manager will report to the Chief Operating Officer (COO) and will be...

  • Quality Engineer

    2 weeks ago

    Galway, Galway, Ireland Quasar Medical | Medical Device Manufacturer Full time

    To ensure that products and manufacturing processes comply with all relevant quality, regulatory, and industry standards. This role will support and enhance the Quality Management System (QMS), ensuring adherence to regulations such as FDA, ISO, and other applicable standards. The Quality Engineer will collaborate with cross-functional teams to identify and...

Medical Device Quality Assurance Specialist

1 week ago

Galway, Galway, Ireland Quasar Medical | Medical Device Manufacturer Full time

Quasar Medical is a leading manufacturer of medical devices, dedicated to delivering high-quality products that meet the highest standards of safety and effectiveness.

About the Role

We are seeking an experienced Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring that our products comply with all relevant quality, regulatory, and industry standards.

Your primary responsibility will be to support and enhance our Quality Management System (QMS), ensuring adherence to regulations such as FDA, ISO, and other applicable standards. You will collaborate with cross-functional teams to identify and resolve quality issues, conduct audits, and lead corrective and preventive actions (CAPAs).

Main Responsibilities:

  • Maintain the Quality Management System (QMS) to ensure compliance with ISO 13485 and other relevant standards, continuously improving QMS documentation and processes.
  • Conduct product and process audits to ensure adherence to quality standards, regulatory requirements, and internal procedures, identifying areas for improvement.
  • Identify and resolve quality issues, collaborating with production, engineering, and other teams to implement corrective and preventive actions (CAPAs) to improve process efficiency.
  • Review and approve documentation such as device history records (DHRs), validation protocols, and change control records, ensuring accuracy and regulatory compliance.
  • Lead investigations for non-conformances, performing root cause analysis and implementing corrective actions to drive continuous improvement.
  • Conduct risk assessments for new and existing products, supporting risk management strategies in accordance with applicable standards.
  • Participate in supplier quality management, ensuring suppliers meet quality standards and conducting audits as needed.
  • Provide training and support to production, engineering, and other teams on quality standards, regulatory requirements, and best practices.
  • Monitor and report on key quality metrics, updating management on quality performance and areas for improvement.
  • Support product development projects, ensuring quality considerations are integrated throughout the product lifecycle.
  • Assist in preparation for regulatory inspections and audits, ensuring the company is always prepared for compliance evaluations.

Requirements:

  • Bachelor's degree in Engineering, Quality Management, or a related field.
  • 3+ years of experience in a Quality Engineer role within a regulated industry (e.g., medical devices, pharmaceuticals, aerospace).
  • 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 in conducting internal and supplier audits.
  • Ability to lead and implement corrective and preventive actions (CAPAs).
  • Knowledge of risk management principles and methodologies.
  • Excellent documentation and communication skills.
  • Ability to work effectively in a cross-functional team environment.