Quality Engineer Sr

Global manufacturer and distributor of medical products with patient-centered solutions.This position executes and coordinates Quality Engineering functions for the organization in sterile and non-sterile processes. The position requires a dynamic, hard-working quality professional with a desire to work for a fast-paced, large corporate organization. In addition to exceptional communication skills, a "roll-up your sleeves" entrepreneurial attitude is expected.ResponsibilitiesLead and coordinate Corrective and Preventive Actions (CAPA) for Customer complaints and process non-conformities.Develop and define measurement equipment and test methods to evaluate and perform component or process inspections.Define effective control plans for warehouse to operations delivery of raw materials' processes.Define and lead continuous improvement projects focused on quality improvement and cost reductions.Perform periodic audits of the accuracy and cleanliness of component storage locations and communicate results with appropriate warehouse personnel.Support the implementation and improvements for Good Manufacturing Practices (GMPs).Serve as an ISO-13485 Lead Internal Auditor, participating in the Internal Audit Program.Ensure compliance with domestic and international regulations associated with product lines and processes.Minimum RequirementsBachelor's Degree in Engineering or an equivalent.3-5 years of Quality Control/Engineering experience.Medical Devices Experience (pharmaceutical, food, or personal care).Supervisory experience desired.Internal / Lead Auditor ISO 13485:2016.MDSAP knowledge/experience.English fluency 85-90%.Office Windows: Word, Excel, PowerPoint, etc.Strong leadership and effective communication skills.Management skills/Decision Making.Six Sigma (BB/GB) and Lean Manufacturing Experience.#J-18808-Ljbffr