Job Description
Quality Engineer - Automation
Job type: PermanentSalary: competitiveLocation: DublinReference: RE-32532754
As operations and projects expand, there is now a need for a quality engineer (automation) for this Dublin-based site on a 12 month contract.
Commutable from Meath, Kildare, Wicklow and Louth, this is your chance to work within a company on the forefront of medical innovation!
As a quality engineer (automation), this role will see you support NPI projects with key focus around customer specification, validation master plan and protocols. You will provide the company with the technical, and quality resources to manage the quality deliverables on selected NPI projects. Coordinate the necessary activities for ensuring the timely closure of internal/external quality issues on projects.
Key Responsibilities:
* Review and approval of validation documentation (protocols & reports)as a quality review against the signed off VMP and customer requirements
* Ensure the archiving and filing of validation documentation associated with the project
* Facilitate equipment FMEA and ensure, with the Program Manager, that the SME is trained to the FMEA process and updated on the relevant FMEA as required
* Drive the close out of change control, deviations, quality continuous improvement identified during the project.
* Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
* Drive solutions in conjunction with the appropriate department to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
* Analysing and reporting of key measures. Review of quality document to drive compliance ie validation reports, metrology reports etc.
* Drafting of the defect library and QSS during OQ with formal hand over to Operational Quality prior to PQ
* Support internal and supplier audits. Play a key role in the preparation and hosting of third party and customer audits.
* Trending and tracking of quality data to drive improvements eg Sampling data, Maternal reviews reports, project protocols and reports.
Requirements:
* Third level qualification, at a minimum to degree level, in Engineering/Quality/Science.
* Minimum of 2 years' post graduate experience of working in a high volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.
* A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
* In-depth knowledge of validations in a Medical Device environment.
* IQ/OQ/PQ expertise with PPK and CPK, FMEA and Risk Assessment for relevant role
* An excellent understanding of plastic process manufacturing.
* Good understanding of computer system validation.
* Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
* Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
Excellent benefits and a highly-competitive salary are on offer here.
To learn more about this role, and to see how you could fit in to this company, get in touch today or the details above!