Sr Quality Release Engineer - Queretaro Site at Abbott Pediatrics

Querétaro, Querétaro, Mexico -

Full Time

Start Date

Immediate

Expiry Date

05 Jun, 26

Salary

0.0

Posted On

07 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Documentation Review, Team Leadership, DHR Review, Batch Records, CoCs Approval, GDP, GMP, Change Controls, Nonconformity Investigation, CAPA, Risk Management, Sterilization Processes, Problem-Solving, Attention To Detail, English

Industry

Hospitals and Health Care

Description

We are hiring Sr Quality Release 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 This role ensures that all medical devices are released in full compliance with applicable regulatory requirements (ISO 13485, 21 CFR Part 820, NOM-241), internal procedures, and customer specifications. The individual oversees the documentation review process, manages the Quality Release team, drives continuous improvement initiatives, and serves as the primary decision-maker for nonconformities related to final product documentation. What You’ll Do Lead and develop the Quality Release team, ensuring workload coordination, performance oversight, and procedural compliance. Review and approve DHRs, batch records, CoCs, and related documentation in accordance with GDP and regulatory standards. Ensure accurate product status updates in quality/ERP systems and escalate documentation or product discrepancies. Support regulatory compliance efforts, including audits and change controls related to product release. Participate in investigations, provide technical justification for acceptance/rejection decisions, and ensure proper containment of nonconforming product. Drive continuous improvement by identifying process gaps, updating SOPs, and supporting CAPA and training initiatives. Collaborate with Manufacturing, Engineering, Supply Chain, and QA teams to ensure smooth product flow and documentation quality. Required Qualifications Bachelor degree +5 years professional experience Advanced English MUST Experience in Medical Divices MUST Knowledge in Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP). Ability to interpret engineering drawings, specifications, inspection data, and test reports. Understanding of risk management principles and CAPA processes. Familiarity with nonconformance investigation methodologies and product release decision-making. Knowledge or experience with terminal sterilization processes (EtO, gamma, e‑beam), including interpretation of sterilization documentation and load release criteria. Soft Skills Excellent communication skills, both verbal and written, with the ability to collaborate across functional teams (Quality, Engineering, Production, Supply Chain). Strong leadership skills with experience supervising or mentoring technical personnel. High attention to detail and commitment to accuracy in documentation review. Strong problem-solving skills with sound judgment when assessing documentation issues or product release risks. Ability to manage multiple priorities in a fast‑paced, regulated manufacturing environment. Strong organization and time‑management skills to ensure timely product release and workflow coordination. Strong analytical and critical‑thinking capabilities for evaluating documentation discrepancies. 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.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

This role ensures all medical devices are released in full compliance with regulatory requirements (ISO 13485, 21 CFR Part 820, NOM-241) and internal procedures, while leading and developing the Quality Release team. The individual oversees documentation review, manages team performance, drives continuous improvement, and makes final decisions regarding nonconformities related to product documentation.