Quality Engineer Posted Date: August 22, 2013



Job Description

Join the global team that transforms patients? lives.
 
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine.  The medical solutions we pioneer enable people to go on living the lives they love. We help clinicians improve patients? lives by delivering innovative medical technologies that lead the world in quality, reliability and efficacy. Since 1998, employees in Cork have been at the forefront of some of these truly innovative medical device designs and manufacturing. 
We are now interested in reviewing suitably qualified and experienced applications for a Quality Engineer to work at our state of the art facility in Cork, Ireland. This is a TEMPORARY (6 month) position.

Purpose Statement                                                                                                                                                     
Act as a member of the Boston Scientific Cork facility Quality Team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant                                                                                     
Key Responsibilities

Supervision of Quality Technicians.

·Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
·Provide effective and responsive QA support to Operations to meet their area?s objectives of quality, cost and output.
Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA?s)
·Drive and implement plant wide quality system improvements.
·Ensure Regulatory compliance in area of responsibility to cGMP?s of all medical device regulatory agencies (e.g. FDA and TUV)
·Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
·Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques)
·Approval of change requests for product, process and quality system changes.
·Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
·Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
·Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements)
·MRB: Review of MRB trends and identification of appropriate corrective actions when required.
·Perform internal quality audits.
·Support the implementation of Lean Manufacturing across the site.
·Transfer and implement product and processes from development or from another manufacturing facility.
·Build Quality into all aspects of their work by maintaining compliance to all quality requirements
 
Typical Education and Experience Guidelines

Minimum qualification: BSC/BEng degree.
Minimum of 2/3 years experience in a QA role.
Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
Strong project management skills.
Good level of technical and analytical expertise to assist in problem solving.
Good knowledge of statistics would also be an advantage.
Experience/training in problem solving methodology. (Engineering Essentials TM)

Experience Required

Typical Education and Experience GuidelinesMinimum qualification: BSC/BEng degree.Minimum of 2/3 years experience in a QA role.Knowledge of GMP regulated environment and experience in a similar role would be an advantage.Strong project management skills.Good level of technical and analytical expertise to assist in problem solving.Good knowledge of statistics would also be an advantage.Experience/training in problem solving methodology. (Engineering Essentials TM)