|Job Ref:||204623736||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Contract||Country:||United Kingdom||City:||Cork||Address:||Salary:||£21.65 - £23.14/hour competitive||Post Date:||06/10/2016 02:18|
Quality Engineer, €30 - €32.07p/hr, Cork - Ireland|
We at Real Staffing are looking for a Quality Engineer to work with a global Pharmaceutical organisation. You will initially be working on a 6 month contract in Cork. This is a fantastic opportunity to join their team.
* Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
* Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
* Conduct benchmarking to develop more effective methods for improving quality
* Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
* Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
* Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
* Analyse/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
* Generate IQ, OQ, PQ, TMV Protocols and Reports
* Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
* A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 2-4 years related experience.
* Experience working in both an FDA and European regulatory environment is preferred.
* This position will require relevant experience working in manufacturing/operations.
* In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
* Experience with a proven track record of implementing appropriate risk mitigation.
* Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
* The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
* Good technical understanding of manufacturing equipment and processes is required.
* Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
* A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
* Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
* Demonstrated project management and project leadership abilities are preferred.
* This position may require up to 10% travel and will be based in an MD&D manufacturing facility.
If you feel this is a suitable role for you then send me a copy of your recent CV and call me on (Apply online only) and we can discuss this further.
If you have any other questions please do not hesitate to get in touch.
To find out more about Real please visit (url removed)
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales