• Manage all quality-related issues within the assign project scope as applicable (e.g. internal, supplier, customer and customer warranty)
• On time completion of assigned activities in accordance with the project plan
• Identify root cause and investigate permanent corrective actions for product quality issues within the assigned project scope
• Ensure control plans and associated documentation are implemented effectively and maintained within assigned project scope
• Ensure compliance and assist with adherence to the applicable Quality Management System (QSR 21 CFR 820, ISO 13485:2016, etc.)
• Write, execute and review TMV’s, IQ’s, OQ’s, PQ’s including completion reports
• Knowledge of the execution, documentation and implementation of SPC (Statistical Process Control) charts.
• Assist with training of quality awareness.
• Knowledge and promotion of the use of customer preferred techniques for continuous improvement such as Six-Sigma, Poka-Yoke (Error Proofing), etc
• Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements as applicable
• Participate in the development and refinement of Design and Process FMEA’s (Failure Mode and Effects Analysis) as applicable
• Keep up with current and developing manufacturing and engineering trends that concern product quality
• Support and lead process improvement activities
• Achieve goals within budget
• Schedule periodic meetings as applicable to inform QA project progress
• BA/BS degree 1-2 years relevant experience OR equivalent combination of education and relevant experience.
• Bilingual preferred (Spanish – English - spoken and written)
• Medical Device Industry experience (2 years min)
|Edad||26 - 60 años|