Supplier Quality Engineer #7562

4 weeks ago

Sligo, Sligo, Ireland Eci Full time

Brief Description
About ECI
ECI's mission is to be the global leader of professional consulting services for the life sciences industry.
Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value.
ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects.
Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role
Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues.
Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
What You'll Do
Support the development and maintenance of supplier qualification/re-qualification activities for suppliers.
Maintain a detailed and practical knowledge and understanding of ISO13485:2016, MDSAP, MDR and ISO Standards.
Support ongoing Quality Improvement projects and initiatives, as required.
Thorough review of existing mold validations
Sub tier supplier controls
Review process controls
Perform other duties as assigned.
What You Will Bring
Engineering / Science degree or Valid Experience in the field.
Awareness of worldwide applicable regulations for Quality Systems (EU MDR, ISO13485, 21CFR820 etc.)
(preferred)
Experience of working within quality processes such as CAPA, Complaint Management, Risk Management (preferred)
Experience of conducting audits to international standards such as ISO 9001:2015 and ISO 13485:2016.
An individual in this role must have results oriented, organization and time management skills with a strong orientation on processes.
The ability to communicate efficiently in an international environment with external partners and key stakeholders.
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future.
At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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