Supplier Quality Engineer III

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 Zona Franca Coyol de Alajuela location in the Electrophysiology 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.

As the  Supplier Quality Engineer III, you’ll have the chance to beresponsible for activities related to supplier selection and evaluation, material qualification, supplier performance, receiving inspection and work very close with Supply Chain team. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements. As required, supervises the activities, manpower and resources within the functional area to ensure support is provided to meet the department and company goals. May provide mentoring for team personnel. 

What You’ll Do

• Assesses potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier. Evaluates, monitor, and approve new and existing external suppliers based in their qualifications and performance, acts as a spokesperson to external suppliers.
• Generates test protocols, monitors testing, issues material qualification test reports and approves components for use. 
• Assists in generating component specifications, generates and maintains incoming inspection procedures and provides input from component quality, inspectability and manufacturability perspective. Trains inspectors to these procedures as required.
• Leads in maintenance and improvement Abbott supplier quality program policies, procedures, and forms.
• May supervise other Supplier Quality Technicians and or receiving inspection personnel.
• Provides engineering guidance to Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
• Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
• Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.

Shift Admin

Required Qualifications

• Bachelor degree (STEM careers) e.g. Chemical Engineer or equivalent of study.

• Experience:
• Supplier Quality engineering: 3 years

Experience in Supplier Quality Engineering or Receiving Inspection, demonstrate work experience in Supplier Roles.

Experience with SAP supply chain modules or similar ERP system.

Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).

Prior medical device experience and supervising personnel.

Demonstrated use of Quality tools/methodologies, such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).

Knowledge of FDA, GMP, QSR CFR 21 Part 820 and ISO 13485.

Experience implementing various product and process improvement methodologies.

Technical writing Experience.

Experience in Auditing Suppliers based on ISO 13485 or 9001.

Intermediate statistics knowledge.

Quality Engineering : 2 years

Experience in Quality Engineering.

Experience with SAP Quality modules or similar ERP system.

Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).

Demonstrated use of Quality tools/methodologies, such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).

Knowledge of FDA, GMP, QSR CFR 21 Part 820 and ISO 13485.

• Intermediate statistics knowledge
• Advance command of English