Johnson & Johnson Careers
Staff Quality Engineer, New Product Introduction, Consumer Eye Health
Jacksonville, Florida; Santa Ana, California; Hangzhou, China
Requisition ID: 3531190829
Johnson & Johnson Vision, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Quality Engineer, New Product Introduction, Consumer Eye Health to be located in Jacksonville, Fl, Santa Ana, CA or Hangzhou, China.
Johnson & Johnson Vision, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the Johnson & Johnson Vision brand and fortifying our position as the worldwide leader in total eye healthcare solutions.
The Staff Quality Engineer, NPI CEH will be responsible for the leadership and support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management and Lifecycle Management for the Consumer Eye Health platform.
The Staff Quality Engineer will:
• Drive design control activities for new product development, design transfer and lifecycle management.
• Drive verification and validation strategies for new product introduction and ensure that critical product characteristics have been identified and properly evaluated.
• Demonstrate proficiency to 21 CFR 820, ISO 13485:2016, ISO 14971:2012 and IEC 62366-1:2015. Audit and approve design control, manufacturing, quality, and validation/qualification documents for conformance to quality system procedures.
• Maintain compliance to applicable ISO product and process standards. Perform gap assessments against these standards and act upon any identified gaps.
• Lead CEH Quality Engineering activities for new product launches through concept, design, development, and steady-state processes.
• Drive prevention and detection of defects at earliest phase of customer requirements, product design, and continuous improvement. Contribute to root cause investigations using various problem-solving tools/techniques and assess effectiveness of corrective actions.
• Provide leadership & support to JJV process excellence initiatives including Six-sigma, design excellence & lean thinking. Apply advanced Quality Engineering/Scientific Method Techniques/Six Sigma/Lean/ and Quality Tools to project deliverables.
• Act as technical liaison between product development, manufacturing, external manufacturers & suppliers.
• Proactively engage stakeholders to drive consensus and resolve internal.
•A Bachelor’s Degree (or international equivalent) in Engineering or relevant science / technical degree
•A minimum of 6 years of related work experience
•Experience in a regulated industry (preferably within medical device)
•Knowledge of 21 CFR 820, ISO 13845 and IEC 62366-1
•Advanced knowledge of Quality Engineering/Scientific Methods and Techniques
•Knowledge of FDA requirements for design control of medical devices, preferably with verification and validation of aseptic processes
•Ability to support domestic and international travel of up to 25%
•Experience with aseptic processing
•Applied statistics of increasing complexity
•New product development experience
•Knowledge of risk management
•Certified Quality Engineer from ASQ and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)
•Previous experience in developing robust requirements traceable to customer requirements and in identifying critical-to-quality product and process elements
•Experience with ensuring that process Quality control plans and Quality procedures are in accordance with product or process risk level and are consistently followed
•Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
•Fundamental technical understanding of supplier quality requirements
This position can be located in Jacksonville, FL or Santa Ana, CA or Hangzhou, China.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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-California-Santa Ana, Asia Pacific-China-Zhejiang-Hangzhou
Johnson & Johnson Vision Care, Inc. (6094)