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:
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
Education
Bachelor's degree Engineering, Science or Technical Field
Experience/Background Experience
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 Language Proficiency
Fully Bilingual (English and Spanish) / Required Capable of maintain fluent oral communication face to face or by conference. Preferred Qualifications & Education
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/AIn specific locations, the pay range may vary from the range posted.