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À propos
Quality Engineer
Industry:
Medical Device Manufacturing
Responsibilities:
Make sure production processes stay compliant with industry standards - ISO 13485 and FDA regulations. Develop and implement quality management system documents. 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 Knowledge of ISO13485 (medical device) and FDA regulations. Experience working within a QMS system Experience with the following - CAPAs, root-cause analysis, FMEA, corrective action, and supplier quality action requests
Preferred Qualifications :
Experience with MasterControl eQMS system Experience within R&D manufacturing Quality certifications / Certified Quality Engineer
Location
- Indianapolis, IN - near downtown
Pay
- $80K - $100K, depending on experience
Compétences linguistiques
- English
Avis aux utilisateurs
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