Johnson & Johnson Careers
Senior Quality Engineer – 3rd shift
Anasco, Puerto Rico
Requisition ID: 2244180523
Johnson & Johnson Vision, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer – 3rd shift.
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.
As the Senior Quality Engineer – 3rd Shift, you will:
• Plan, conduct and direct Engineering projects or studies requiring advanced knowledge of a specialized field.
• Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
• Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements.
• Conduct benchmarking to develop more effective methods for improving quality and review the effectiveness of Plan-Do-Check-Act (PDCA), Six Sigma, Kaizen, Lean Techniques and other improvement tools/programs.
• Review and analyze current product and processes, ensure they follow standards such as the Quality Systems Regulations (QSR) and ISO 13485.
• Champion compliance to applicable global regulations and standards including providing support during internal and external audits, conducting periodic line audits to assess production controls such as lot segregation, and reviewing results of area audits to ensure that corrective and preventive actions are adequate.
• Lead/maintain Material Review Board, conduct investigation, bounding, documentation, review and approval of non-conformances, Corrective & Preventive Actions (CAPA) and customer complaints, and escalate quality issues as appropriate.
• Own material identification, material segregation, classification of defect types, and Quality metrics.
• Analyze/review effectiveness of CAPA and review root cause investigation according to an established process. As well as, develop, write or approve Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), or Software Validation.
• Partners with Johnson & Johnson 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.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSR.
• A minimum of a bachelor’s degree in Engineering is required, preferably in Chemical or Mechanical Engineering.
• Quality, Process Excellence or Project Management certifications (e.g. CQE, CQA, PMI, PMP, Green Belt, Black Belt) are preferred.
• A minimum of four (4) years of experience in Quality, Operations or Engineering in a manufacturing regulated environment is required.
• Experience in validations, investigations and root cause analysis is required.
• Experience in the Medical Device or Pharmaceutical industry is required.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) and experience implementing appropriate risk mitigation is required.
• Thorough understanding of Good Manufacturing Practices (GMP)/ISO/validation regulations, demonstrated project management abilities, and experience applying statistical techniques are required.
• Technical training and experience using Lean Six Sigma methodologies including Measurement System Analysis, Statistical Process Control (SPC), Design of Experiment (DOE), and Reliability is preferred.
• Proficiency in English and Spanish (oral and written) is required.
• Proficiency with Microsoft Office tools (Word, Excel and PowerPoint) is required, as well as, Intermediate Excel skills (e.g. pivot tables, vlookup). Experience with Minitab is preferred.
• Availability to work in a 3rd shift and to work extra hours, weekends or visit other shifts as per operational needs are required.
• This position requires up to ten percent (10%) of travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Puerto Rico-Anasco
AMO Puerto Rico Manufacturing, Inc. (Branch) (7239)