Under direct supervision from Quality System Manager, this position has the purpose to 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. This position works with minimum supervision, have responsibility for quality compliance for all products produced in the Terumo, Puerto Rico LLC (TPR) facility. Assignments are broad in nature and Associate uses discretion to design project task and to bring the project to completion. May supervise QA/QS exempt and non-exempt position.
Essential Duties and Responsibilities:
* Review plant defect reports, customer complaints, failure investigations and audit findings to assess manufacturing related issues that may impact quality and recommend courses of corrective action.
* Perform manufacturing and review 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. Assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions when required.
* Perform and report line defects trend analysis, cost of quality, and period quality summaries.
* Participate in new product or technology transfers to assess the impact they may have on the quality and reliability of the product ? assist in process validation protocol.
* Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends.
* Perform and report line defects trend analysis, cost of quality and period quality summaries.
* 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.
* Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement.
* May have supervisory responsibility over Quality Technicians, Quality Engineers, receiving and in-process inspection (QC) personnel.
* Ensure compliance with all TPR procedures and all applicable regulatory agency requirements.
* Other duties as assigned.
* Knowledge, Skills and Abilities (KSAs):
* Must have fundamental knowledge/experience in statistics, SPC, validation activities, Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification.
* Knowledge in DOE, Six Sigma and product transfer.
* Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP and, auditing principals.
* Prior experience auditing FDA regulations.
* Must be bilingual (English and Spanish), possess good communication and analytical skills, and availability to work under deadlines.
* Credentials of a Certified Quality Engineer are a plus.
* Must be able to apply comprehensive knowledge of a particular field of specialization to the completion of assigned task.
* Background Experiences:
* Bachelor's degree in Engineering (Industrial, or CQE preferred) required, advanced degree or process towards advanced degree is a plus.
* Must have 5+ years' experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry.