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Details
Senior Design Quality Engineer
Reference: | JCAO010121 | Location: |
Galway |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | 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
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2020 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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