What are the responsibilities and job description for the Quality Assurance Engineer position at Aegis Worldwide?
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
Salary : $90,000 - $100,000