Johnson & Johnson Surgical Vision is recruiting for a Staff Quality Engineer , located in Milpitas, California, USA .

Remote work options will not be considered for this position.

At Johnson & Johnson Vision , we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

The Staff Quality Engineer is responsible for providing guidance on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards. Plans and conducts projects and assignments with technical responsibility or strategic feedback. The Staff Quality Engineer will generally operate more independently and may mentor or coach less experienced QEs.

Responsibilities include:

• Supports the application of quality engineering and quality compliance for demanding projects including projects involving multiple sites or design houses in the areas of:
• New product development / new product introduction / new process introduction
• Supply chain (life cycle engineering, manufacturing, assembly, or supplier quality)
• Quality systems / business improvement
• Develops standard operating procedures, specifications, and provides technical transfer and validation support.
• Develops and implements projects to achieve governance objectives; tracks progress against schedules; provides timely status reports; and communicates status to management
• Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation
• Maintain alertness to changes in the industry and regulatory environments and apply this information to business practices at Johnson & Johnson.
• Provide support and expertise in the implementation of GMP, ISO and FDA requirements
• Prepare QA (Quality Assurance) system and assist in technical issues for manufacturing processes that are to be transferred to satellite facilities
• Handle established processes in support of steady state manufacturing in accordance with defined QA program for product transfers
• Provide statistical support and expertise in DOE (Design of Experiments) and analytical problem solving for manufacturing, technical services, and product development in order to:
• Minimize sample and scrap waste
• Assess reliability and risks based on data presented
• Identify root cause of problems
• Reduce and identify sources of variation
• Audit and approve manufacturing, quality, engineering, and validation qualification documents for conformance to Johnson & Johnson business practices and departmental procedures
• Support development of validation strategy
• Act as liaison to Regulatory Affairs department to perform initial regulatory review of all engineering changes to modifications to products
• Perform analysis of documents I information to ensure that all critical product characteristics have been identified and accurately evaluated:
• Design specification
• FMEA (Failure Mode Evaluation and Analysis): Product and Process - Material
• Specification
• QA system (in-line control points) - FGI results
• Product inquiry analysis
• Reliability analysis
• Provide sampling plans and approve inspection, methods for evaluation and testing of components and products
• Support Continuous Release program, where applicable to reduce need for FGI inspection
• Support program to eliminate Post-Cobalt FGI Testing for product release
• Provide support and expertise in reliability strategy and reliability growth demonstration during new product development
• Other responsibilities and not all responsibilities listed may be assigned

Qualifications

Education:

• A minimum of a bachelor’s degree in Engineering is required

Required Skills & Experience:

• A minimum of 6 years of work experience
• Experience in a regulated industry
• Personal computer skills, Windows: word processing, project planning, presentation, e-mail, and spreadsheet software
• Strong technical understanding of manufacturing equipment and processes
• Experience with Validations
• Experience with Design control, GDP, GMP and organizational requirements
• Experience with Root cause analysis and Corrective Action / Preventive Action (CAPA) expectations
• Plan and perform basic reliability testing and analysis
• Experience leading projects and demonstrating project leadership abilities

Preferred Skills & Experience:

• ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Engineer) or CRE (Certified Reliability Engineer) certification
• A Green Belt in one or more of the Process Excellence roadmaps (DMAIC, or Lean)
• Industry experience in medical device, biopharmaceutical, or pharmaceutical
• Advanced knowledge of Quality Engineering/Scientific Method techniques and principles
• Applied statistics of growing complexity

Other:

• This role is based in Milpitas, California and could require up to 10% domestic and international travel.
• The anticipated base pay range for this position for California Candidates is $102,970.70 to $144,239.90

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]