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Role: Quality Engineer P1 REQ: ****** Role Type: Permanent, no shift, onsite assigned Closing Date: October 13th **** 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 Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, 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 Incoming Inspection area to ensure efficient supply to production areas.
Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
Approval of change requests for process and quality system changes.
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