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General Electric Quality Assurance Engineer in Monterrey, Mexico

Role Summary:The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering

process support in accordance with documented procedures and practices. The Quality

Assurance Engineer is a key technical role responsible for the development, implementation,

improvement and continuous reinforcement of established total quality fundamental practices

that are utilized in the local business. The role involves hands-on work in the areas of design

transfer, change control and manufacturing

Essential Responsibilities:Responsible for ensuring quality and regulatory compliance in accordance with

documented procedures for all aspects of functional responsibility.

 Responsible for the development, implementation, continuous improvement of process

effectiveness and efficiency at the site and execution of a variety of tasks as assigned by

departmental manager to improve process/product quality and customer experience.

 Ensures process efficiency and regulatory compliance during implementation of controls

for the different products manufactured such as: Equipment Qualification and Process

and Software Validation, Process control and product monitoring, acceptance activities,

measurement equipment calibration, change control, design transfer activities and their

respective change control mechanisms, that may include: development, review, approval

of procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and

other product and process related documentation.

 Ensures risk control activities (pFMEA, control plans) are executed in compliance with

documented procedures and required tools to ensure effective process controls are

established and ensuring linkage with Design mitigations.

 Supports continuous product and process improvement through executing audits, failure

analysis for non-conformances, and investigates, develops and implements effective and

compliant solutions for product or process corrections, corrective and preventive actions.

 Partners with cross-functional team to identify and resolve functional issues aligned to

business and site priorities

Qualifications/Requirements:1. Bachelor’s Degree.

  1. 1-3 years of experience in manufacturing, engineering, quality assurance experience

Desired Characteristics:Knowledge of Six-sigma tools/ problem solving / statistical techniques

  1. Significant Multi-Modality Sites: Minimum 3 years Quality Assurance/Quality Engineering

experience in the medical device or pharmaceutical industry

  1. Small and Simple Sites: Minimum 2 years Quality Assurance/Quality Engineering

experience in the medical device or pharmaceutical industry

  1. Experience with Medical Device QMS requirements and regulatory requirements including

but not limited to FDA CFR 21 820 and ISO 13485Demonstrated knowledge of Quality

Management System tools, continuous improvement methodologies & in-depth

understanding of site level products & related processes

  1. Demonstrated understanding of product development lifecycles, design change and

document change control, process verification and validation methodologies,

manufacturing / production process control methodologies, and servicing in a medical

device environment.

  1. Demonstrated expertise to effectively communicate within all levels of the organization

around concepts of design controls, design verification and validation activities;

production &process controls; Corrective & Preventive Action (CAPA), complaints & risk

management; & product quality improvement using tools such as six sigma, DFR, etc.

  1. Demonstrated collaboration, negotiation & conflict resolution skills

  2. Excellent oral communication & report, business correspondence & procedure-writing

skills

  1. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy

under crisis situations to ensure compliance

  1. Change agent with energy, passion & enthusiasm to drive change

  2. Exceptional analytical, problem solving & root-cause analysis skills

  3. Ability to multi-task & handle tasks with competing priorities effectively

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.comAdditional Locations:Mexico;Monterrey;

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