Quality Engineer - P1 at Boston ScientificAdditional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformancePurpose StatementDemonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in BSC.Understanding and complying to BSC’s quality, business, health & safety systems and market/legal regulations governing the quality systems.Removing or mitigating against risks associated with the design, use and manufacture of BSC devices.Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.Key ResponsibilitiesGeneralCompletes work assignments under limited supervision/guidance.Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.Seeks to support improvements in product and process quality.Builds Quality into all aspects of work by maintaining compliance to all quality requirements.Excellent interpersonal and communication skills with good leadership abilities.TechnicalProvides both quality and technical input to ongoing product development, product sustaining and post-market commercial product activities.Experienced in post-market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, and regulatory requirement changes.Analytical and problem‑solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.EducationMinimum of Bachelor of Science Degree Level 8 in Engineering/Technology.1/2 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.Requisition ID: 615509Seniority levelNot ApplicableEmployment typeFull-timeJob functionOtherIndustriesMedical Equipment Manufacturing
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