Senior Quality Engineer

hace 9 horas

Tijuana, México Outset Medical Mexico A tiempo completo

The Quality Engineer will focus on development of Process Validation strategies, non-conformances, MRB, CAPA’s, tracking and reporting on monthly basis and compiling and presenting data for management review, execution, and approvals of change orders. Essential Job Functions and Responsibilities Core Job Manufacturing process sustaining (Cleanroom environment). Sterilization concepts and product release. Contractor´s management, such as external laboratories and sterilization sites. Quality Inspectors management. Supporting NPI’s activities from SJ Facility to MX facility by developing and executing the transfer validation strategy. (IQ, OQ or PQ) Change orders for process improvements and determines when process stability and capability studies should be performed on existing processes. Analyzes and performs failure analysis to non-conforming products. Leads in the implementation of assurances, process controls, nonconformances and CAPA. Reviews and participates in the update/creation process FMEA’s, application FMEA’s, and risk benefit analysis for medical devices. Develops and prepares monthly quality trend analysis and reports. Interpersonal skills Leads, coaches, and mentors non-exempt and entry level exempt personnel. A self-starter, motivated and able to positively motivate others. Focused, target driven with a positive, can-do attitude. Support additional activities, as assigned. Required Qualifications Bachelor's degree in engineering or technical field or equivalent experience is required. Minimum of 5+ years of experience. Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971. Able to read and understand technical data. Competent using Microsoft Office suites. Strong written and verbal communication in English. Desired Qualifications Good analytical, communication (both verbal and written) and presentation skills. Statistical analysis software a plus. Effective analytical, technical, and problem-solving skills. Ability to multi-task and manage multiple assignments in a timely manner. Strong analytical skills. Quality engineering certification, Lean Six Sigma certification. #J-18808-Ljbffr

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