Johnson & Johnson Vision, part of the Johnson & Johnsons Family of Companies, is recruiting a Senior Quality Engineer for its facilities located in Añasco, Puerto Rico. Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Key Responsibilities: Supports quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive requirements) including providing support during internal and external audits Drives product quality, implements controls and handles dispositions by providing support to investigations, bounding, impact evaluations, and by reviewing and approving nonconformance reports, CAPAs and customer complaints while raising quality issues as appropriate Supports Product/Process Qualification activities by developing and/or approving validation documentation for execution of IQs, OQs, PQs, TMVs and CSV Assesses the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability and process controls Partners with J&J Global Supply chain, finished goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed Ensures effective quality strategies are built for the validation of test methods, process and design Qualifications A minimum of a Bachelor’s degree in Engineering is required. A minimum of four (4) years of related experience in Medical Device or Pharmaceutical industry is required. Deep understanding of GMP/ISO regulations and validation regulations is required. Experience in both an FDA and European regulatory environment with quality related experience working in manufacturing/operations is required. In-depth knowledge of product/process Risk Management (FDA and ISO standards) and proven track record of implementing appropriate risk mitigation is required. Technical training and intermediate to advanced experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, is required. Advanced technical understanding of manufacturing equipment and processes is required. Advanced project management and project leadership abilities is required. Proficiency in English and Spanish (oral and written) is required. Proficiency with Microsoft Office tools (Word, Excel) is required. Knowledge in SAP, Minitab, ETQ is preffered. Available to work other shifts, extra hours and weekends based on operational needs. The position requires up to ten percent (10%) of domestic travel. Availability to work second 2nd Shift (2:00pm-10:00pm) PE or Licensed Professional preferred.
