Quality Assurance Engineer

Job Title: Quality EngineerIndustry: Medical Device ManufacturingResponsibilities:Make sure production processes stay compliant with industry standards - ISO 13485 and FDA regulations.Develop and implement quality management system documents.Conduct audits with the quality team, preparing reports and data for these ahead of time.Conduct analysis of manufacturing processes and products - charting quality issues within the QMS and implementing corrective actions.Risk Management activities - risk analysis/FMEA and corrective actionsManage nonconformances within the production process - pinpointing these and finding ways to rework the product or avoid the quality issue moving forwardSupplier quality - SCARs (supplier quality action requests) and auditing of suppliers to make sure quality standards are met.Software validation activities - IQ, OQ, PQCAPAs and root cause analysisR&D manufacturing - assisting with this and development of new products/processesTrain and develop quality associatesParticipate in continuous improvement and safety projects with the engineering teams.Required Qualifications:Bachelor's degree in Engineering5+ years of engineering / progressive quality experience leading to engineeringMust have medical device experienceKnowledge of ISO13485 (medical device) and FDA regulations.Experience working within a QMS systemExperience with the following - CAPAs, root-cause analysis, FMEA, corrective action, and supplier quality action requestsPreferred Qualifications:Experience with MasterControl eQMS systemExperience within R&D manufacturingQuality certifications / Certified Quality EngineerLocation - Indianapolis, IN - near downtown