Assurance Design Project Manager

1 week ago

Galway, Galway, Ireland beBeeProject Full time €60,000 - €90,000

Job Title: Assurance Design Project Manager

Description: We seek a skilled professional to lead quality assurance efforts in product development. As a key member of our organization, you will be responsible for leading project teams and providing guidance on establishing design history files / device master records documentation.

Key Responsibilities:

  • Develop detailed clinical, pilot production, and scale-up plans for new product introduction programs.
  • Ensure project teams utilize Nordson Medical Quality Systems and industry standards throughout the product development process.
  • Evaluate material biocompatibility and sterilization methods during product design.
  • Conduct risk assessments of designs to determine functionality.
  • Implement timely corrective actions, change control, and notification procedures.
  • Interact with customers and suppliers in a professional manner.
  • Audit and qualify new suppliers as needed.
  • Resolve technical issues when they arise.
  • Ensure all work satisfies quality manual requirements.

Required Skills and Qualifications:

  • Bachelor's degree in Engineering or related field.
  • 6+ years of medical device design and quality assurance experience.
  • Strong customer relationship management skills.
  • Ability to lead product verification & validation activities.
  • Experience working with operations to develop manufacturing process instructions and operator training.

About the Opportunity: Our global leader in the medical device industry seeks an experienced project manager to join their team. You will have the opportunity to work on complex medical devices and component technologies.

  • Design Assurance Specialist

    3 days ago

    Galway, Galway, Ireland beBeeQuality Full time €50,000 - €70,000

    Design Quality Assurance Engineer RoleThis role is a key part of our Design Quality Assurance team, responsible for ensuring the highest standards of quality are met in medical device design.The successful candidate will be responsible for executing sound quality practices and maintaining an effective quality system. They will support the application of...

  • Senior Design Assurance Project Lead

    4 days ago

    Galway, Galway, Ireland beBeeQualityManagement Full time €60,000 - €80,000

    Job Title: Project Manager Design Assurance Job Summary:This role involves leading quality representatives on projects, contributing to and providing guidance to others in establishing appropriate Design History File/Device Master Record documentation.Key Responsibilities:Develop detailed plans for clinical, pilot production, and scale-up processes in New...

  • Design Assurance Expert

    3 days ago

    Galway, Galway, Ireland beBeeDesign Full time €72,000 - €93,600

    We are seeking an experienced Design Assurance Engineer to play a pivotal role in supporting the lifecycle of our commercially released medical device products.Key ResponsibilitiesManage design changes, ensuring continued compliance with risk management and design control requirementsSupport complaint investigations to uphold the safety and effectiveness of...

  • Design Assurance Engineer

    1 week ago

    Galway, Galway, Ireland AMA Consulting Group LLC Full time

    Neurent Medical is seeking a highly motivated and experienced Design Assurance Engineer to join our team. This individual will play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and...

  • Design Assurance Engineer

    6 days ago

    Galway, Galway, Ireland AMA Consulting Group LLC Full time

    Neurent Medical is seeking a highly motivated and experienced Design Assurance Engineer to join our team. This individual will play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and...

  • Design Assurance Professional

    1 week ago

    Galway, Galway, Ireland beBeeDesignAssurance Full time €73,100 - €98,100

    Job Title: Design Assurance Engineer">About the Role:">We are seeking a skilled and experienced Design Assurance Engineer to support the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and supporting complaint...

  • Design Assurance Director

    2 weeks ago

    Galway, Galway, Ireland beBeeDesignAssurance Full time €80,000 - €100,000

    Design Assurance Program ManagerA Senior Quality Assurance Leader is required to oversee design assurance programs, ensuring accurate documentation and adherence to regulations throughout product development.Lead a team of professionals to ensure the Design History File / Device Master Record is accurately documented.Develop and implement quality systems...

  • Design Quality Assurance Engineer

    4 weeks ago

    Galway, Galway, Ireland Nordson Medical Ireland Limited Full time

    Design Quality Assurance Engineer page is loadedDesign Quality Assurance EngineerApply locations Ireland - Galway time type Full time posted on Posted 30+ Days Ago job requisition id REQ45745Nordson Medical, a global leader in the medical device industry, is seeking an experienced and highly motivated individual to join our team inGalway, Irelandas aDesign...

  • Senior Design Assurance Engineer

    2 weeks ago

    Galway, Galway, Ireland Medtronic Vascular Galway UC Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life Medtronic At Medtronic, we value what makes you unique.Be part of a company that thinks differently...

  • Senior Design Assurance Engineer

    2 weeks ago

    Galway, Galway, Ireland Medtronic Vascular Galway Uc Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life Medtronic At Medtronic, we value what makes you unique.Be part of a company that thinks differently...