Boston Scientific Quality Engineer - P1 

Ireland, Cork 

37976355

• 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).
• Management of Sterile Returns and IDD processes.
• 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.
• Participate in internal quality audits.
• Support the implementation of Lean Manufacturing across the site.

Education & Experience

• Minimum of Bachelor of Science Degree in Engineering/Technology.
• 2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
• Experience in the medical device industry is an advantage.