Quality Engineer I
Duration: 12 Months
Location: Galway, Hybrid Role
Responsibilities:
* Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle Requalification, Supplier Change control etc.
* Support sterility assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites.
* Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation.
* Support cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards.
* Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
* Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
* Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
* Performs calculations, data integrity checks, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
* Adhere to all relevant site wide procedures and practices for Safety & GMP.
Required Knowledge and Experience:
* Requires broad theoretical job knowledge typically obtained through advanced education.
* Requires a University Degree.
* 1-2 years of experience required.
For further information, contact Alan on alan@accpro.ie
Seniority level
* Associate
Employment type
* Contract
Job function
* Quality Assurance
* Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Staffing and Recruiting
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