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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Senior Design Quality Engineer


Reference:JCAO010121 Location: Galway
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer, Senior Quality Engineer


Senor Quality Design Engineer


Our client a Medical Device multinational currently seeks a Senior Quality Design Engineer to join their team. The Senior Quality Design Engineer will be responsible for providing on-going design and quality assurance expertise and leadership in an EMEA Centre of Excellence team


Role/Responsibilities


  • Provision of on-going regulatory compliance, risk management, design control, quality systems and overall design assurance expertise and leadership to the EMEA Centre of Excellence team on an on-going basis.
  • Provision of regulatory and quality systems leadership to the team as it transitions to Design Ownership (Design Authority).
  • Liaison with corporate, local and EMEA sites quality systems and regulatory affairs personnel to ensure team’s compliance and to drive alignment and harmonization.
  • Monitoring of the release and updates to regulatory & quality standards, regulations and policies, execution of gap analysis, communication of changes to the team and driving compliance.
  • Driving the implementation, maintenance and update of procedures that ensure packaging and labelling design controls are met.
  • Creating and maintaining risk management documentation.
  • Providing independent quality review for design reviews, project design plans, risk management, design validation protocols & reports for both design and development projects.
  • Support the team in their design & development activities, carried out on behalf of other EMEA sites.
  • Support the establishment of a Packaging Testing Laboratory in the Galway site.
  • Support the integration of the team into the site QMS.
  • Provide direction for documentation Control, CMS (Change Management System) and CAPA processes.
  • Manage communications with regulatory bodies such as BSI.
  • Provide leadership in the preparation for and during audits. Take the lead and front the team’s participation in audits.



Skills/Experience


  • Bachelor’s degree / HETEC Level 8.
  • A minimum of 5 years’ relevant experience in a Design Assurance - Quality Engineering field in a medical device or other FDA 21 CFR 820 or ISO 13485 regulated environment.
  • Must have experience in the preparation for and participation in ISO audits.
  • Experience in packaging and labelling design assurance very desirable.
  • Qualified auditor to FDA 21 CFR 820 or ISO 13485 desirable.
  • Demonstrated ability to deliver results, meet deadlines and expedite critical project completion.
  • Strong technical capabilities.
  • Strong people and communication skills.
  • Proven ability to work well as part of a team and on own.
  • Ability to lead virtual teams, including cross-site teams.
  • Strong written and verbal communication skills, with ability to communicate effectively to multiple levels of the company.

For further information contact James Cassidy [email protected] or call in confidence 0860204322