Quality Engineer

3 weeks ago

Cork, Cork, Ireland Boston Scientific Gruppe Full time

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing – whatever your ambitions.
Advancing possibilities for a brighter tomorrow
We are seeking a
Quality Engineer II on a permanent basis
to join our team.
Job Purpose:
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:
Drive and implement process improvements to ensure predictable processes across shipping and boxpack processes (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

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