Quality Engineer

The Opportunity

As a Quality Engineer you will ensure compliance to company/divisional policies and procedures and with FDA and ISO requirements by reviewing non-conformances, complaints, defect reports, and audit findings in order to coordinate corrective action. Will have responsibility for quality compliance for all products produced in the facility. Will work with minimum supervision and has appreciable latitude for implementing actions. Assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion.

This position works in our Structural Heart manufacturing business in Caguas, Puerto Rico at the first shift Monday to Friday will support Quality Operations.

What You'll Do

Maintain inspection procedures for the inspection of incoming materials, in-process materials and finished goods. Select appropriate inspection, test and measurement equipment, fixtures, and gauges. Participate in continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement. Perform qualifications assigned. Perform and report line defects trend analysis, cost of quality, and period quality summaries. Participate in the development, delivery, and administration of quality training programs including GMP and contamination control. Perform or review manufacturing non conformances reports, customer complaints, CAPA, failure investigations and audit findings to report manufacturing related issues that may impact quality and recommend courses of corrective action. Participate in regulatory agencies audits. Perform quality system audits in order to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor. Participate in the development, delivery, and administration of quality training programs including but not limited to GMP. Perform or assist in the investigation of product non conformances and gathering of information during regulatory inspections and field actions. Ensure compliance with all procedures and all applicable regulatory agency requirements. Other duties as assigned.

Required Qualifications

Bachelor's degree in engineering is required. 2+ years of prior experience in manufacturing, quality control, quality assurance, or regulatory compliance is required. Prior experience in medical device or pharmaceutical manufacturing is preferred.  Must have fundamental knowledge of concepts, practices, and procedures of a particular field of specialization.  Must have fundamental knowledge/experience in statistics, SPC, validation activities, Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification.  Project Management is desirable. Knowledge in DOE, Six Sigma and product transfer is a plus.  Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.  Risk Management knowledge. Knowledge in CAPA, Nonconformance Technical Writing, Process & Software Validation, MES System. Must be bilingual (English and Spanish), possess good communication and analytical skills, and ability to work under deadlines. 

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