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Quality Analyst x2

Location: Cork, Republic of Ireland Salary: €150 - €200 per day
Sector: Consultancy Type: Contract
Reference #: CR/065693_1574360525

Quality Analyst x2 / Cork / 6 months / Start ASAP

The job holder will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and client R&D personnel ensuring timely communication to all stake holders to effect successful project completion.

Key responsibilities:

− Represent Quality as part of a cross functional team to ensure delivery of projects (NPI's and Technology) into production with the highest level of quality, compliance, and adherence to timelines
− Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
− Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production
− Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
− Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development
− Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.
− Lead QA input to Design for Manufacture activities on site.
− Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR's and ISO 13485/9001 requirements etc. during all day to day
− Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.

Key Skills/Knowledge:

* Culturally aware
* Flexible
* Team player
* Good influencing skills
* Project Management skills
* Good generalist (experienced quality person)
* Methodical
* Defuser, not inflamer
* Good communicator
* Politically sensitive
* Travel Flexibility

Experience required:

* A degree level or similar qualification in mechanical or industrial engineering.
* Good experience in a quality role within a regulated industry.
* Proven ability to successfully introduce new product development in the Medical Device Industry.
* Proven knowledge and ability regarding product verification and process validations.
* Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
* Proven experience and training in Mechanical Engineering processes.