Quality Assurance Specialist

hace 3 semanas


Tijuana, Baja California, México Outset Medical A tiempo completo

Job Summary

The Quality Engineer will play a crucial role in ensuring the development and implementation of Process Validation strategies, non-conformances, MRB, CAPA's, tracking and reporting on a monthly basis, and compiling and presenting data for management review, execution, and approvals of change orders.

Key Responsibilities

• Environmental and microbiological testing, such as non-viable and viable particles counting.
• Cleanroom environment sustaining.
• Sterilization concepts and product release.
• Contractor management, such as external laboratories and sterilization sites.

Supporting Activities

• 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 determining when process stability and capability studies should be performed on existing processes.
• Analyzing and performing failure analysis to non-conforming products.
• Leading in the implementation of assurances, process controls, nonconformances, and CAPA.
• Developing and preparing monthly quality trend analysis and reports.
• Leading, coaching, and mentoring non-exempt and entry-level exempt personnel.
• Interpersonal skills.
• A self-starter, motivated, and able to positively motivate others.
• Focused, target-driven with a positive, can-do attitude.

Requirements

• Bachelor's degree in engineering or technical field or equivalent experience is required.
• Minimum of 3-5 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.
• Statistical analysis software a plus.
• Effective analytical, technical, and problem-solving skills.
• Ability to multi-task and manage multiple assignments in a timely manner.
• Good communication and interpersonal skills.
• Advanced English.
• Strong analytical skills.



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