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.

• 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.