Sr. Software QE

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.

• 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

• Bachelor's degree Engineering, Science or Technical Field
• 5 - 6 years experience in Quality 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 maintain fluent oral communication face to face or by conference

• 401k matching
• Health insurance
• Flight privileges

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