Sr. Software QE

Abbott; Santiago de Querétaro; Presencial; MXN 60,000 - 80,000; Jornada completa

Descripción de la vacante

A leading healthcare company in Querétaro is looking for a Supervisor Sr. for their Microbiology Laboratory. This role involves providing technical expertise in quality engineering, managing routine lab activities, and ensuring compliance with FDA regulations. Ideal candidates will have a Bachelor's degree in a relevant field, along with 5-6 years of experience in Quality Engineering roles. Proficiency in English and Spanish is a must. Abbott promotes diversity and offers various opportunities to grow your career.

Servicios

Career development opportunities

A supportive work culture

Recognition as a great workplace

Formación

• Minimum 5-6 years of experience in Quality Engineering positions.
• Experience in FDA, GMP, and ISO 13485 regulated environments.
• Knowledge of software validation for medical devices.

Responsabilidades

• Design software requirements and test plans for non-product software.
• Manage test planning and execution efforts.
• Lead cross-functional teams related to software quality improvements.

Conocimientos

Fluent in English and Spanish

Quality Engineering

Statistical/data analysis

Compliance with FDA regulations

Cybersecurity knowledge

Educación

Bachelor's degree in Engineering, Science or Technical Field

Herramientas

MS Excel

MS Word

MS PowerPoint

Descripción del empleo

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

The Supervisor Sr. will serve as a key member at the Microbiology Laboratory. The position will be responsible for providing technical expertise, consultation and project support. Provide direction consistent with the laboratory program, planning, budgeting and system documentation. This position will be responsible of the Microbiology Lab personnel facilitation, training and development, as well as ensuring the routine laboratory activities are completed to successfully support production requirements.

What You’ll Do

With minimum supervision, the Senior Software Quality Engineer will design software requirements, protocols, test plans, scripts, and reports to validate non product software, using the non-product software development life cycle procedure, also it will identify, analyze, 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, as well as apply the software quality methodologies to ensure that all non-product software adhere to regulations and standards

Main Responsibilities

• Supports customers on non-product software validations for accuracy, adequacy, and compliance with the non-product software development lifecycle, Quality System, Part 11, Data Integrity, Cybersecurity and FDA regulations
• Execute, reviews and support on-time completion of Software Quality Engineering deliverables: software requirements, validation test plans, code reviews, test scripts, test reports, software inventory reports
• Manage and leads test planning and execution efforts by a combined, team of testers located onsite and/or offshore
• Establishing & maintain strong trust-based peer relationships cross-functionally
• Supports and/or leads cross-functional project teams (local or international) related to non-product software and quality improvements
• Based on key performance indicators data, may support activities focused on maintaining indicators under control for CTQ, budget or other indicators deemed necessary
• Represents the SW QE department on a CAPA investigation teams and can lead high complexity root cause issue investigations related to software
• Provides guidance, leads, supports development and retention of other software quality engineers
• Serves as the primary site representative for external regulatory inspections and audits in case of absence of a Software Quality Engineer Lead, Software Quality Manager, or higher representative rank in relation to non- product software related audits
• Can perform other assignments according to the requirements of the business or upper management

Required Qualifications

• Bachelor's degree in Engineering, Science or Technical Field
• 5 - 6 years experience in Quality Engineering positions
• At least 5 years of experience in Quality or Manufacturing Engineering positions
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint)
• Knowledge of statistical/data analysis and report writing experience
• Experience working on FDA, GMP, and ISO 13485 Regulated environments
• Knowledge on product and process qualification and validation
• Fully Bilingual (English and Spanish), capable of maintaining fluent oral communication face to face or by conference
• FDA Class II or Class III medical device experience, preferred
• Quality or Lean Certifications (i.e. Six Sigma Belt, ASQ CQE/CSQE), preferred
• Ability to travel to support domestic and international manufacturing sites (up to 15%)
• Knowledge of software validation for medical devices and/or non-product software validation
• Knowledge of cybersecurity for medical devices and/or non-product software
• Knowledge of data integrity and ALCOA+ principles for medical device software and non-product software

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