More jobs:
Quality Assurance Engineer
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-06-26
Listing for:
Ripple Foods
Full Time
position Listed on 2026-06-26
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
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 HIRELOCATION:
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 Master Control 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.
- 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 Master Control 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
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