Senior Quality Engineer for Cardiac Rhythm Management, this position is based in Arecibo, Puerto Rico.

As the Senior 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. This position will have responsibility for quality compliance for all products produced in the Abbott-CRM facility. This position works 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.

What You’ll Do

• 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. (Weight=20%)

• Perform or assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions. Recommend corrective actions. (Weight=15%)

• 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. (Weight=10%)

• Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends. (Weight=5%)

• Perform and report line defects trend analysis, cost of quality and period quality summaries. (Weight=10%)

• 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. (Weight=10%)

• Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement. (Weight=10%)

• May have supervisory responsibility over Quality Technicians, Quality Engineers, receiving and in-process inspection (QC) personnel. (Weight=5%)

• Ensure compliance with all Abbott procedures and all applicable regulatory agency requirements. (Weight=10%)

• Other duties as assigned. (Weight=5%)

Required Qualifications

• Bachelor's degree in engineering required.

• Advanced degree or process towards advanced degree is a desirable. Credentials of a Certified Quality Engineer are desirable.

• Minimum 6 years in a similar position in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry.

• 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 is a desirable.

• Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP and, auditing principals.

• Prior experience auditing FDA regulations preferred.

• Bilingual proficiency in English and Spanish, with strong conversational, written, and reading skills.

• Strong communication and analytical skills, with the ability to manage multiple priorities and deliver high-quality results in time sensitive environments.

The base pay for this position is $66,000.00 – $132,000.00. In specific locations, the pay range may vary from the range posted.