Quality Engineer - Queretaro Site

Quality Engineer - Queretaro site in Mexico

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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 position works out of our Queretaro site in Mexico in EP Division. 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.

Works closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR’s, MA’s, Yield, Cost Reduction projects, etc.) and support/lead process/product validation activities.

Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtain support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements.

Owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).

Responsible for supporting and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support, validations and Quality Metrics.

Works with minimum supervision and assignments are broad in nature. Employee uses knowledge to propose alternatives tasks and to bring projects to completion.

What You’ll Do

• Verify company’s adherence to the established Quality System and GMP/ISO standards.
• Provide support and coaching to lower-level engineering positions and guidance to other areas of the organization on Quality related topics.
• Completion of risk management and risk analysis including FMEA.
• Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis.
• Conduct technical and statistical investigations concerning optimization and compliance to specification.
• Owner of measuring process capability, process controls, and process validation efforts.
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
• Own NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
• Works closely with Sr. quality position on completing and documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.
• Leading Build At Risk (BAR) Authorizations, approvals & closures.
• Own, complete or approve document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
• Creation and maintenance of Quality Plans and Reports. Also, provide support to lower level engineering positions.
• Own, execute, review or approve of IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, and mentorship from higher level engineering.
• Conduct Advanced Statistical Data Analyses using Minitab.
• Author Master Validation Plans and Reports / Quality Plans and Reports.
• Support activities during preparation and execution of audits (External / Internal), functioning as SME backup for specific Quality activities.
• Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.).
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support, coach, and mentor non-exempt and entry-level exempt personnel.
• Create and communicate details and information of events related to quality to upper management.
• Participate as listener and presenter in management meetings such as QDR, KPIs and Management Review.
• Perform other duties and responsibilities as assigned by senior management.
• Perform supervisory activities for Quality Technicians, if required.

Required Qualifications

• Education: Bachelor Degree (University Level) in STEM (Science, Technology, Engineering preferred), with experience in medical devices or pharmaceutical quality control preferred.

Experience

• 4-6 years’ experience in Quality or Engineering positions.
• At least 4 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 with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
• Experience working in FDA, GMP, and ISO 13485 Regulated environments.
• Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
• Project management experience, participating or leading multi-departmental project teams.

Language Proficiency

• Advanced Commands of English / Required: Fluent oral and written communication including technical writing.

Preferred Qualifications & Education

• ISO 13485 certification as Lead Auditor or similar.
• Experience with SAP.
• ASQ CQE / Six Sigma certification or similar.
• Participation or leading multi-departmental project teams.
• Experience in a supervisory role.
• Available to travel long periods for training.

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.

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