Offers “General Electric”

Expires soon General Electric

QA Engineer

  • Internship
  • Ciudad Juarez, MEXICO

Job description



3432263
Additional Cities

Ciudad Juarez
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

Mexico
Postal Code

32575
Role Summary/Purpose

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 responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.
Essential Responsibilities

·  Develop audit plans/agendas for corporate GMP compliance assessments/audits based on risk taking into account current regulatory focus and business needs.
·  Execute GMP compliance audits/assessments.
·  Produce timely, detailed and technically correct reports following assessments/audits.
·  Communicate identified deficiencies and compliance risks to appropriate business, operations and quality heads.
·  Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and expectations and requirements. Approve proposed CAPA/ remediation plans, regularly review progress & effectiveness, and continue to give ongoing support in all compliance matters.
·  Provide advice, guidance and support to sites for external audits, as requested.
·  Conduct pre-approval/pre-submission project reviews (e.g. products, facilities), “mock” inspections as part of the Global GMP Compliance Assessment program. Provide guidance for timely remediation.
·  Advise, guide and support sites in the overall regulatory inspection management. 
·  Perform regular analysis of regulatory observations made at sites, prepare and coordinate the global follow-up/gap analysis to prevent re-occurrence and provide advice Participate in the continuous improvement and maintenance of Quality System and Compliance risks.
·  Participate and lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives. 
·  Develop Quality standards and processes based on expertise and assigned areas.
Qualifications/Requirements

·  Bachelor's degree in engineering.
·  Communication, organization and documentation skills.
·  Quality experience in a GMP environment for 3 or more years.
·  Experience as a GMP auditor for 2 or more years.
·  Bilingual.
Desired Characteristics

·  Statistics education and or training.
·  Experience developing and tracking quality metrics.
·  Familiar with Continuous Improvement methodologies, including Six Sigma.
·  Knowledge in international GMP regulations and guidelines especially in US / EU for medical devices.
·  Experience in international regulatory inspection management incl USFDA.
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.com
Primary Country

Mexico
Primary State/Province

Chihuahua
Primary City

Ciudad Juarez

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