Ingeniero de Calidad

Abbott; Santiago de Querétaro; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A global healthcare leader in Querétaro is seeking a Quality Engineer to ensure compliance with quality systems and support process validation. The ideal candidate will have at least 2 years in Quality or Engineering, strong analytical skills, and experience in regulated environments. This position offers significant responsibilities in maintaining quality standards and conducting investigations. Join a company that values diversity and growth and provides opportunities to advance your career.

Servicios

Career development with an international company

Recognition as a top employer

Commitment to diversity

Formación

• 2+ years of experience in Quality or Engineering roles.
• Proficient in MS applications and statistical analysis.
• Experience in FDA, GMP, and ISO 13485 environments.

Responsabilidades

• Verify compliance with quality systems and standards.
• Conduct NCMR investigations and audits.
• Lead the creation of Quality Plans and Reports.

Conocimientos

Risk management

Statistical data analysis

FDA knowledge

Root Cause Analysis

Six Sigma

Educación

Bachelor's degree in STEM

Herramientas

MS Excel

Minitab

Descripción del empleo

JOB DESCRIPTION

Quality Engineer - Querétaro Site

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.

About 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.

Main Purpose of the Role

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/owns process/product validation activities. Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. Support of Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).

Main Responsibilities

• Verify company´s adherence to the established Quality System and GMP/ISO standards.
• Assist in completion of risk management and risk analysis including FMEA.
• Work with R&D/Design verification and design validation plans for products based on performance specification and risk analysis.
• Supports 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.
• Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
• Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations with minimum mentorship from higher level engineering.
• Leading Build At Risk (BAR) Authorizations & Closures.
• Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
• Creation and maintenance of Quality Plans and Reports, typically with minor mentorship from higher level engineering.
• Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with minimum mentorship from higher level engineering.
• Conducting Statistical Data Analyses using Minitab typically with mentorship from higher level engineering.
• Maintenance/update Master Validation Plans and Reports.
• Supports activities during preparation and execution of audits (External / Internal).
• Perform supervisor activities to Quality Technicians, if required.

Education

Bachelor’s career : STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control)

Experience

• At least 2 years of experience in Quality or 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.
• Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
• Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
• Knowledge on product and process qualification and validation.

Other Qualifications and Education

• ASQ CQE / Six Sigma or similar certification
• Participation or leading multi-departmental project teams
• Experience in supervision role

Language proficiency

English Intermediate- advanced Required

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.

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: Standard TRAVEL: No MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable