Quality Engineer

Quality Engineer

This role offers an excellent opportunity to work within a highly regulated ISO 13485 environment, supporting quality assurance, regulatory compliance, distribution quality oversight, and continuous improvement initiatives across distribution and operational networks. The successful candidate will play a key role in maintaining quality system compliance, supporting investigations, and driving process improvements.
Key Responsibilities
  • Support quality assurance programmes, procedures, and controls for medical devices and finished goods.
  • Review, plan, coordinate, and implement change controls while assessing quality and regulatory impact.
  • Collaborate with Manufacturing Engineering and Operations teams on risk assessments, process improvements, and quality initiatives.
  • Lead and support investigations relating to non-conformances, CAPAs, and quality system issues.
  • Conduct root cause analysis and implement effective corrective and preventive actions.
  • Monitor quality performance trends and utilise statistical tools to identify improvement opportunities.
  • Support validation activities, including strategy development, sampling plans, and execution for new and existing product lines.
  • Ensure compliance with ISO 13485, Quality Management Systems (QMS), and applicable regulatory requirements.
  • Identify potential quality and compliance risks and support mitigation activities.
  • Drive continuous improvement projects to enhance operational efficiency and maintain regulatory compliance.
  • Work closely with Supply Chain, Operations, and Engineering teams to ensure effective quality oversight.
Skills & Experience
  • Bachelor’s Degree in Engineering, Science, or a related discipline.
  • 3-5 years’ experience within a regulated Medical Device environment.
  • Strong working knowledge of ISO 13485 and Quality Management Systems (QMS).
  • Experience managing change controls, CAPA investigations, and non-conformance processes.
  • Knowledge of risk management methodologies, including FMEA (Failure Mode and Effects Analysis).
  • Experience with root cause analysis and structured problem-solving techniques.
  • Strong communication skills with the ability to present technical information to both technical and non-technical stakeholders.
  • Proficient in Microsoft Office applications, including Excel, Word, and PowerPoint.

Equipment Development Engineer

Equipment Development Engineer

Summary

The Equipment Development Engineer will lead equipment development and automation projects that support site and global strategic objectives. The role focuses on equipment design, validation, integration, risk management, and lifecycle support within a regulated manufacturing environment.

Responsibilities

  • Lead equipment development, automation, and integration projects from concept through implementation.
  • Manage equipment vendors, including selection, qualification, and ongoing performance.
  • Oversee equipment validation activities, including URS, FDS, SDS, FAT, SAT, IQ, and software validation.
  • Drive projects supporting key business objectives, including safety, cost reduction, efficiency improvements, and obsolescence management.
  • Conduct equipment risk assessments and implement mitigation plans throughout project lifecycles.
  • Identify and manage equipment, tooling, component, and software obsolescence programs.
  • Ensure equipment is designed and implemented in accordance with safety and ergonomic standards.
  • Support Manufacturing with scale-up activities and new equipment integration.
  • Manage equipment changes through formal change control and Management of Change (MOC) processes.
  • Provide technical leadership and project updates to stakeholders while supporting continuous improvement initiatives.

Experience

  • Degree qualification (Level 8 or equivalent) in Engineering or a related discipline.
  • Proven experience in equipment development, automation, and validation within a regulated manufacturing environment.
  • Experience with equipment and software validation methodologies, including GAMP 4/5 standards.
  • Knowledge of GMP and ISO 13485 requirements, preferably within the Medical Device industry.
  • Experience with equipment risk assessments, process validation, and change management.
  • Familiarity with PLCs, electrical systems, and IT/OT integration is advantageous.
  • Exposure to Lean Manufacturing and Six Sigma methodologies is desirable.
  • Strong project management, problem-solving, and stakeholder management skills.
  • Ability to manage multiple projects and communicate effectively across cross-functional team

Distribution Quality Engineer

Distribution Quality Engineer

We are currently recruiting for an experienced Distribution Quality Engineer to join the EMEA Distribution Quality team. This position offers an excellent opportunity for a quality-driven professional to expand their experience within a highly regulated medical device environment. The role will focus on quality assurance, regulatory compliance, distribution oversight, and continuous improvement activities across distribution centres, service and repair facilities, and third-party distributor networks.

Key Responsibilities

  • Support post-market quality assurance programmes, policies, procedures, and controls relating to medical devices, combination drug/device products, filtration products, and finished goods
  • Oversee warehousing, storage, distributor operations, and service and repair activities throughout the EMEA region
  • Lead and support continuous improvement initiatives to maintain compliance across internal distribution centres, service and repair sites, and external distributors
  • Ensure adherence to global quality and regulatory standards including US 21 CFR 210, 211 and 820, ISO 13485, ISO 14971, EU MDR, Health Canada, MHRA, TGA, and other applicable international regulations
  • Participate in projects supporting site and country-level quality system compliance, including storage requirements, local language over-labelling, and product ship hold processes
  • Collaborate closely with Operations and Supply Chain teams to maintain effective oversight of global distribution and service networks
  • Contribute to quality improvement initiatives through process monitoring, root cause analysis, trend evaluation, and issue resolution activities
  • Support the ongoing maintenance of quality management oversight processes across global distribution and third-party networks
  • Identify potential quality and compliance risks and assist in implementing corrective and preventive actions (CAPAs) where necessary

Skills & Experience

  • Bachelor’s degree in Science or a related discipline, or equivalent qualification
  • Minimum of 5 years’ experience working within an ISO 13485 regulated medical device environment
  • Strong working knowledge of ISO 13485 and Quality Management Systems (QMS)
  • Experience managing quality systems within distribution centres (DC/3PL), distributor networks, and service & repair operations
  • Good understanding of international medical device quality and regulatory requirement

Environmental Health and Safety Engineer

Environmental Health and Safety Engineer

We are searching for an experienced EHS Engineer. This is a great opportunity for an experienced professional to further grow their skills. The role focuses on risk management, continuous improvement while fostering a strong safety culture ensuring alignment with regulatory and industry standards.

Responsibilities

  • Manage and maintain the site risk assessment schedule, driving initiatives to reduce workplace risks
  • Ensure compliance with EHS legislation and ISO 14001 and ISO 45001 standards
  • Oversee Management of Change processes, ensuring all EHS considerations are addressed for new and existing projects
  • Support sustainability initiatives across energy, water, and waste reduction programmes
  • Promote a safety-first culture across all departments, supporting teams in understanding and meeting EHS requirements
  • Deliver EHS training and support site engagement activities related to health, safety, and wellbeing
  • Monitor and review EHS performance, ensuring continuous improvement across site operations

Skills and Experience

  • Degree or qualification in EHS, Health & Safety, or a related discipline; NEBOSH or equivalent preferred
  • Strong knowledge of ISO 14001 and ISO 45001 standards
  • Experience within manufacturing, pharmaceutical, or a similar regulated environment
  • Solid understanding of risk management and EHS systems
  • Strong organisational and documentation management skills
  • Proficient in EHS management systems and software tools
  • Excellent communication skills with the ability to influence and engage stakeholders at all levels

Service Technician Driver

Service Technician Driver

Field-Based Service Technician

We’re looking for a flexible individual to join our client, providing exceptional customer service and technical support to improve patients’ lives.

What you will be doing- Full Training Will Be Provided

  • Installation/service of medical oxygen equipment.
  • Installation/service of ventilation equipment.
  • Providing training and technical support to our patients and their families.
  • Providing product knowledge to both private sector and Hospital environment.
  • Provide after-hours patient support on a roster basis.

What we are looking for:

  • Outstanding People Skills – You enjoy working with patients and delivering top-tier customer service.
  • Strong Communication Skills – Excellent verbal and written skills are essential.
  • Technical Expertise & Attention to Detail – Experience in technical repairs is advantageous.
  • IT Proficiency – Comfortable using computers and working with IT systems.
  • Adaptability & Initiative – Willing to take on varied tasks and responsibilities.
  • Valid Driving Licence (2+ Years) – A full, clean driving licence is required.
  • Geographic Knowledge – Nationwide Travel will be essential.
  • Location – Must be based in Dublin however nationwide travel is necessary
  • Industry Experience (Preferred, Not Essential) – Experience in the homecare medical device field is beneficial, but full product training will be provided.

If you are interested in a long term career in home healthcare services, this is an excellent opportunity to join a progressive company where an attractive remuneration package plus a company vehicle, PDA and mobile phone are provided.