Quality Assurance Engineer

Aegis Worldwide is currently partnered with an Indianapolis medical device manufacturer hiring for a Quality Assurance Engineer! This company is currently going through an ISO 13485 certification and this is a new role for the company, as additional support is needed for this certification process and long-term thereafter. Details are below but if you're interested, please submit an application and we'll schedule a call! DIRECT HIRE LOCATION : Indianapolis, IN SCHEDULE : Monday-Friday, fully onsite SALARY : $90,000 - $100,000 JOB TITLE: Quality Assurance Engineer INDUSTRY : Medical Device Manufacturing RESPONSIBILITIES : Make sure production processes stay compliant with industry standards while working toward a company-wide ISO 13485 certification. Develop and implement quality management system (QMS) documents. Complete technical writing of SOPs, work instructions, and QMS processes, working within MasterControl eQMS. 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 actions Supplier quality – SCARs (supplier quality action requests) and auditing of suppliers to make sure quality standards are met. Software validation activities – IQ, OQ, PQ CAPAs and root cause analysis R&D manufacturing – assisting with this and development of new products/processes Train and develop quality associates Participate in continuous improvement and safety projects with the engineering teams. REQUIREMENTS: Bachelor’s degree in Engineering 5+ years of engineering / progressive quality experience leading to engineering Must have medical device experience / experience with ISO 13485 regulations. Experience working within a QMS system, preferably MasterControl eQMS but others are acceptable. Experience writing technical instructions, SOPs, and QMS documents. Experience with the following – CAPAs, root-cause analysis, FMEA, corrective action, and supplier quality action requests Show more Show less