Associate Quality Engineer

The Opportunity

This position works out of our Arecibo location in the CRM division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Shift : First shift- Monday to Friday

As the Associate Quality Engineer, you will provide Process / Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. The Associate Quality Engineer will work with line supervisor, manufacturing engineer, and other team members, to address all opportunities found in the assigned manufacturing line and will be the primary quality representative for the area.

What You’ll Do

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventive actions.
• Works with line support team (QC Supervisor, Mfg. Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and initiate exception management process.
• Owns basic exception / CAPA activities with management oversight.
• May be responsible for working with process owner to bound product stops and document release criteria.
• Responsible for lot-to-lot yield and rework evaluation.
• Gains understanding of product quality plans, documents, and systems by reviewing product specifications, quality specifications, and working with quality systems.
• Assists in development of product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• May be responsible for providing input to risk analyses and FMEAs.
• Learns Process Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
• Becomes familiar with Product / Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development.
• Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
• Assist Product / Process improvement efforts (e.g). scrap, nonconforming product, customer complains) by systematically gathering quality metric data and by assisting in the appropriated analysis methods to enhance sustaining product design.
• Runs routine problem-solving investigation with direction and use of basic engineering principles.
• Implements minor changes through change management system and may support major change implementation.
• May write protocols and reports with management oversight to support engineering studies and validations.

Required Qualifications

Preferred Qualifications