
Quality Assurance Director
8 hours ago
- Develop and implement a comprehensive QA/RA strategy aligned with business objectives and regulatory requirements.
- Oversee global regulatory submissions and communications with the FDA, EMA, and Notified Bodies.
- Ensure compliance with EU MDR, FDA 21 CFR Part 820, and other applicable regulations.
- Manage internal and external audits, CAPAs, and risk management activities.
- Collaborate cross-functionally with R&D, Clinical, and Operations to ensure regulatory and quality requirements are met throughout the product lifecycle.
- Monitor changes in global regulations and standards, and proactively update internal processes.
- Mentor and develop the QA/RA team, fostering a culture of compliance and continuous improvement.
- Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
- Proven years of working experience in QA/RA within the medical device industry.
- Proven experience with FDA submissions (510(k), PMA) and EU MDR compliance.
- Strong knowledge of IEC 62304, IEC 60601, and ISO 14971.
- Experience leading audits and managing QMS under ISO 13485.
- Excellent leadership, communication, and project management skills.
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Director Of Quality/Regulatory
17 hours ago
Galway, Galway, Ireland Hobson Prior Full timeAre you a strategic thinker who is experienced in Quality Assurance and Regulatory Affairs?This Director position could be your next best moveHobson Prior is searching on behalf of our client who are seeking an experienced and strategic Director of QA/RA to lead their Quality Assurance and Regulatory Affairs functions.This role is critical in ensuring their...
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Quality Assurance Professional
16 hours ago
Galway, Galway, Ireland beBeeAssurance Full time €55,000 - €70,000Quality Assurance SpecialistWe are seeking an experienced Quality Assurance Specialist to join our team in Galway. The ideal candidate will have a strong background in quality management and be able to work effectively in a production environment.Responsibilities:Monitor compliance with quality standards and procedures, providing coaching and training as...
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Quality Assurance Expert
12 hours ago
Galway, Galway, Ireland beBeeQuality Full time €80,000 - €100,000Job Title: Quality Assurance ExpertOur organization is seeking a Quality Assurance Expert to oversee quality systems, internal manufacturing processes, and supplier relationships.This role will report directly to the Chief Operating Officer (COO) and be responsible for maintaining the company's Quality Management System (QMS), supervising quality...
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Quality Assurance Specialist
2 weeks ago
Galway, Galway, Ireland beBeeQuality Full time €50,000 - €75,000Discover Your Future in Quality AssuranceJob OpportunityWe are seeking a diligent Quality Assurance professional to join our team.Evaluate complex product exceptions and develop effective solutions.Make informed decisions regarding product quality, including the disposition of non-conforming products.Promote excellence in product and process quality through...
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Principal Quality Assurance Specialist
16 hours ago
Galway, Galway, Ireland beBeeDesign Full timeJob Title: Senior Design Assurance EngineerJob Description:We are seeking a highly skilled Senior Design Assurance Engineer to join our expanding team. As part of the Design Assurance team, you will be responsible for demonstrating commitment to quality by executing sound quality practices and maintaining an effective quality system.The successful candidate...
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Design Assurance Quality Lead
2 days ago
Galway, Galway, Ireland beBeeQuality Full timeJob Title: Design Assurance Quality LeadAbout the RoleWe are seeking a seasoned quality assurance professional to lead our design assurance program. In this role, you will be responsible for ensuring that all design activities meet the required standards and regulatory requirements.Key ResponsibilitiesLead quality representative on projects, contributing to...
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Quality Assurance Specialist
7 hours ago
Galway, Galway, Ireland beBeeQuality Full time €60,000 - €100,000Quality Assurance SpecialistThis role focuses on ensuring the highest quality of products and services.The ideal candidate will have excellent communication skills, a strong background in quality engineering, and experience working in agile environments. They should be able to effectively collaborate with cross-functional teams and provide input for process...
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Senior Quality Assurance Specialist
13 minutes ago
Galway, Galway, Ireland beBeeQuality Full time €80,000 - €120,000Senior Quality Assurance SpecialistWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Receiving Inspection Department. The ideal candidate will have a strong background in quality assurance, inspection methods, and process improvements.Main Responsibilities:Evaluate inspection processes and develop effective solutionsCreate and...
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Senior Quality Assurance Specialist
13 minutes ago
Galway, Galway, Ireland beBeeDesign Full time €60,000 - €90,000Job DescriptionThe ideal candidate will have a strong background in quality assurance and 2+ years of experience working in the medical device industry.Key Responsibilities:Collaboration with R&D teamsActive participation in project teamsDocumentation of quality control activitiesRequirements:Quality control experienceUnderstanding of user...
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Design Quality Assurance Engineer
1 week ago
Galway, Galway, Ireland Nordson Medical Ireland Limited Full timeDesign 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...