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