Quality Engineer

3 days ago

Cork, Ireland Boston Scientific Gruppe Full time

OverviewDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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.Role: Quality Engineer P1REQ: ******Closing Date: October 13th ****Purpose StatementAct 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.ResponsibilitiesDrive 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.QualificationsEducation: Minimum of Bachelor of Science Degree in Engineering/Technology.Experience: 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.Additional InformationRequisition ID:******As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal.And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with youJob Segment: Quality Engineer, Facilities, Medical Device Engineer, Medical Device, Compliance, Engineering, Operations, Healthcare, Legal#J-*****-Ljbffr

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