Über
Quality Assurance Engineer
Industry:
Medical Device Manufacturing
Location
- Indianapolis, IN - near downtown
Pay:
$80K - $100K, depending on experience
Schedule : Monday-Friday, 7AM-4PM / 8AM-5PM
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 Manage nonconformances within the production process - pinpointing these and finding ways to rework the product or avoid the quality issue moving forward 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.
Required Qualifications :
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
Sprachkenntnisse
- English
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