Senior Product Analysis Quality Engineer - (Job Number: 0806094)

Senior Product Analysis Quality Engineer - (Job Number: 0806094) DescriptionLifeScan, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Senior Product Analysis Quality Engineer, for the facility located in Aguadilla, PR. The selected candidate will be performing data Analysis, documentation and reporting on escalations from the Product Analysis Lab. Assures compliance with regulations and promotes good product quality engineering practices. Manage data collection, escalation decisions and reporting for Photometric Strips complaints. Present escalation data to the Product Monitoring and Improvement team and participate in corrective action decisions. Work with U.S. Product Support, Operations and other cross-functional teams to investigate hospital product defects. Partner with the CAPA department and process owners of CAPAs for information sharing and data correlation. Develop and implement new test procedures and test protocols for new products and novel complaint types. Continually improve LifeScan's product quality engineering processes. Improve technical expertise and understanding of regulatory requirements. Identifies, recommends and implements initiatives for the continuous improvement of processes. Develops and review Processes Control Plans, Process FMEA's and Process Change requests. Develops and review validation protocols and reports as necessary. Leads complaint investigation team. Reviews and approves nonconformance reports and complaint investigation reports as deem necessary. Perform other work'related duties as assigned. Bachelor's degree in Engineering (Chemical or Industrial will be preferred). Five to eight years of experience in Product Quality Engineering in the medical device or pharmaceutical industry. Supervisory experience will be a plus. Fully bilingual (English & Spanish). PE, Six Sigma, Lean and/or CQE certifications will be a plus. A 15% of travel time outside Puerto Rico is required. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position! Apply Now