Offers “General Electric”

Expires soon General Electric

QA Engineer / Documentation

  • Ciudad Juarez (Juárez Municipality)
  • Bachelor's Degree
  • Design / Civil engineering / Industrial engineering

Job description

2888005
City

Ciudad Juarez
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country

Mexico
Postal Code

32575
Role Summary/Purpose

The Quality Assurance Engineer / Documentation is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices, document management and document control processes that are utilized in the local business.

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, and continuous improvement of process effectiveness and efficiency at the site.

·  • Supporting and assessing QA document management processes and tools.

·  • Supporting continuous process improvements and standardization through data analysis, Lean efforts, etc.

·  • Leading and/or participating in the development and implementation of employee training around document management and control.

·  • Participating in efforts to ensure audit-readiness and helping in the resolution of documentation issues, as required.

·  • Providing information and guidance to QA personnel with regard to the development and control of quality system documentation, as required.

·  • Participating in the development and maintenance of document standards, naming/numbering conventions, and templates for QMS procedures, work instructions, and other relevant document types.

·  • Ensuring that documents comply with established templates, formats, and identification/naming/numbering standards.

·  • Supporting/managing document workflow and ensuring compliance with relevant GEHC Document Management procedures and work instructions, as required.

·  • Ensuring that document reviews and approvals are managed in an efficient and effective manner.

·  • in the identification and removal of old/obsolete procedures and work instructions, as required.

·  • Managing and controlling specific quality records, as required.

·  • Supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).

·  • Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.

·  • Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.

Quality Specific Goals:

·  Aware of and comply with the GEHC Quality Policy, the GEHC Quality Manual, Quality Management System Procedures and Work Instructions, Quality Goals, and applicable laws and regulations as they apply to this job type/position;

·  Complete all planned Quality & Compliance training within the defined deadlines

·  Identify and report any quality or compliance concerns and take immediate corrective action as required

·  Consistent application of QMS documentation standards; 100% compliance with established templates, naming conventions, and storage requirements

Qualifications/Requirements

Qualifications:

·  Bachelor's degree plus 3 years experience in document control, Quality Engineering or Quality Assurance Management in a QA/RA or medical device/pharmaceutical environment;

·  A minimum 1 year experience working in a regulated environment, preferably medical device or pharmaceutical

·  A minimum of 1 year of experience using document control strategies or methods in a regulated environment.

·  Strong working knowledge of the English language;

·  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.

Desired Characteristics

Preferred Qualifications:

·  Strong knowledge of medical device and/or pharmaceutical regulations (FDA, ISO)

·  Certificate from certified QMS course (i.e. ASQ, CQA) and 5 years in auditing/regulatory process (Auditor).

·  A minimum of 2 years experience in document control or training, applying regulations and/or standards such: as FDA, Sirs, ISO, etc.

·  Minimum of one-year experience documenting complaints and/or corrective and preventive actions.

·  Previous experience in a specific function (complaint handling, document control, etc.)

·  Coursework in Quality Assurance/Control and/or Regulatory Assurance.

·  Strong process improvement mindset, passion for quality.

·  Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.

·  Skills and experience in the area of auditing (GAC Auditor) including conducting audits, documenting findings, tracking corrective/preventive actions, validating corrective/preventive actions and closure.

·  Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).

·  Demonstrated effective interpersonal and effective teamwork skills.

·  Excellent oral and written communication skills.

·  Analytical & problem-solving skills/root-cause analysis.

·  Strong organizational skills with high attention to detail.

·  Prior experience using word processing, spreadsheet, and presentation software

About Us

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

Make every future a success.
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