Quality Engineer

3 weeks ago

Galway, Galway, Ireland Hero Recruitment Full time

Quality Engineer 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 resolve quality issues, conduct audits, and lead corrective and preventive actions (CAPAs).
Key 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.Education and Experience: 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.
#J-18808-Ljbffr

  • Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland Cregg Group Full time

    Quality Engineer - Galway (Permanent) CREGG Recruitment are hiring for a Quality Engineer to join a leading medical manufacturing company in Galway.Level 7 qualifaction accepted.Great opportunity for a Senior Quality Technician to progress in an engineering role.For more information contact Gary: garykeane@ Role Summary The Quality Engineer, reporting to the...

  • Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland Oxford Global Resources Full time

    Quality Engineer Are you a quality engineer looking for a new opportunity? Are you interested in joining the development process of medical device products for a fast scaling company? Don't hesitate, and apply today Overview: Our client is seeking a Quality Engineer, supporting the quality assurance aspects of a manufacturing ramp-up.The successful...

  • Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland Smart Reactors Service Limited Full time

    Quality Engineer (R&D)Full Time Job DescriptionSmart Reactors are currently seeking a Quality Engineer to join our team located in Parkmore, Galway, Ireland.About Smart ReactorsSmart Reactors is headquartered in Galway, Ireland and is a trusted provider of medical device coating technologies. We provide solutions to reduce thromboembolic complications, while...

  • Quality Engineer

    4 weeks ago

    Galway, Galway, Ireland Cpl Healthcare Full time

    Quality EngineerSligo – PermanentI am looking to speak with candidates with Quality Engineering or QA specialist experience in a GMP Quality environment for a growth role in this expanding company.The successful candidate will support review and approval of validation documentation and activities related to the qualification of the facility, equipment and...

  • Quality Engineer

    17 hours ago

    Galway, Galway, Ireland Jnjmedtech Full time

    At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the...

  • Quality Engineer

    4 weeks ago

    Galway, Galway, Ireland McHale Full time

    McHale are looking to recruit a Graduate Quality Engineer to join our Quality team in our production area. This is a full-time permanent position based at our Head Office in Ballinrobe. The ideal candidate will be be eager to learn and has the ability to work effectively and independently.KEY RESPONSIBILITIES:Ensuring that suppliers deliver quality product...

  • Quality Engineer

    17 hours ago

    Galway, Galway, Ireland Johnson & Johnson MedTech Full time

    At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the...

  • Quality Assurance Engineer

    2 weeks ago

    Galway, Galway, Ireland beBee Careers Full time

    Quality Assurance EngineerWe are seeking a Quality Assurance Engineer to support our R&D Department in managing and implementing ISO 13485 quality systems. This role will involve collaborating closely with internal teams to ensure compliance and promoting a culture of quality across the organization.Coordinate, upgrade, and maintain the ISO13485 QMS...

  • Quality Engineer Ii

    3 weeks ago

    Galway, Galway, Ireland Sigmar Recruitment Full time

    Quality Engineer II About Your New Employer Join a global leader in medical device in Galway.We are looking for an Quality Engineer II to join on a 12-month contract.You will be part of a dynamic and supportive team that values innovation and excellence.As a Quality Engineer II, youll play a pivotal role in supporting the development and implementation of...

  • Senior Quality Engineer

    4 weeks ago

    Galway, Galway, Ireland Sigmar Recruitment Full time

    Senior Quality Engineer About Your New Employer A fast-growing company developing medical devices About Your New Job as a Senior Quality Engineer Manage document control ensuring consistent and compliant processing. Represent quality in R&D meetings, providing advice and documentation reviews. Participate in risk management to ensure all risks are mitigated...