Quality Analyst x2
Posted on Nov 23, 2019 by Red - The Global SAP Solutions Provider
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.
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 ie 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.
* Culturally aware
* Team player
* Good influencing skills
* Project Management skills
* Good generalist (experienced quality person)
* Defuser, not inflamer
* Good communicator
* Politically sensitive
* Travel Flexibility
* 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.