Software Quality Engineering - Queretaro Site

JOB DESCRIPTION:

We are hiring Software Quality Engineer About Abbott

Abbott, global leading healthcare company, is investing in Mexico. We are building a manufacturing facility in Querétaro.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

This facility will offer 1,200 local new jobs and will be the first health manufacturing facility in Querétaro (pioneers for healthcare Hub).

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Work in the implementation of Electrophysiology Software Quality Systems, ensuring the business / plant continuity through Good Manufacturing Practices (GMP) compliance of documental system, non-conformities, Corrective Action Preventive Action (CAPA), Complaints, Self-Inspections /Audits, Risks systems, among others Quality systems. Works closely with Quality, Manufacturing and Engineering on sustaining and projects activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR’s, projects, etc.).

What You’ll Do

• Work in the implementation of Electrophysiology Software Quality Systems to ensure business/plant continuity through GMP compliance
• Design software requirements, protocols, test plans, scripts, and reports to validate non product software, using the non-product software development life cycle procedure and support process validation activities, qualification, working with multidisciplinary areas
• Identify, standardize and document software validations to meet current regulations and medical industry standards
• Provides guidance, maintain, leads and/or develops other software quality engineers in the Non product software Lifecyle.
• Apply the software quality methodologies to ensure that all non-product software adhere to regulations and standards
• Works closely with Quality, Manufacturing, IT, Microbiology, Calibration, and Engineering on sustaining and projects activities to ensure compliance with the quality system requirements
• Provide guidance and understanding of the quality management system procedures (related with software), as well as support to ensure compliance with current regulatory requirements. It will offer coaching and support to achieve objectives and may provide feedback or escalate situations if internal and/or regulatory requirements and policies are not met.
• Coordinate, approve and ensuring software requirements and compliance with CFR21, FDA and other applicable regulations

Qualifications

• Bachelor’s/Engineering degree (completed)
• +5 years in in the same rol
• Advanced English (mandatory)
• Experience in regulated industries (medical devices/pharma)
• Computer System Validation (CSV)
• +3 years Project Management
• Knowledge of FDA, GMP, ISO 13485
• Systems: MES, SAP, Power BI, MS Office
• Self-driven, results-oriented
• Strong cross-functional collaboration skills

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EP Electrophysiology

LOCATION:

Mexico > Queretaro : Avenida FINSA 156, Lote 12

ADDITIONAL LOCATIONS:

WORK SHIFT:

Turno 1 Day Shift (Mexico)

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable