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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
Pharma Sales Connected Health Supply Chain Clinical Research Validation Engineer Mayo Sales and Marketing Cork Academic Pharmaceutical Life Science Dublin Laboratory Scientist Medical Device Scientific Academic Manufacturing Executive Quality Engineering Quality Control Supply Chain PhD Engineering Packaging Engineer Microbiology IT Biopharmaceutical Product Development Engineer Diagnostics Medical Affairs Scientist Chemistry Sales and Marketing Allied Healthcare Biotechnology Cork City Limerick Quality Assurance Project Manager
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 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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