Quality Engineering 1

About the role

Johnson & Johnson is a global healthcare company committed to innovative medicine and medtech. This role is within the Quality Engineering team, supporting new and sustaining product/process teams.

Responsibilities

• Support design verification tests, process validations, and quality processes
• Work with other functional groups, including R&D and Operations, on new product development, engineering projects, quality assurance activities, and lifecycle management
• Utilize Quality Engineering tools and processes in the development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle
• Lead efforts for continuous quality and customer satisfaction improvement opportunities
• Support Non-Conformance Report (NCR) process for BWI facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA
• Write, review, and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders
• Analyze data using statistical tools like Six Sigma, SPC, DOE, etc., to make acceptance decisions and improve process capability
• Ensure development activities follow design control requirements, meet applicable standards, GSPR, and product transfer specifications
• Perform technical problem solving, failure analysis, and root cause determination
• Make decisions independently on engineering problems and represent the organization in conferences to resolve important questions and plan work
• Assign/review quality inspection testing and test data
• Keep department supervisor informed of activities and issues within the quality group

Qualifications

• Bachelor’s degree in engineering or scientific discipline
• 0-2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
• Demonstrated auditing and problem-solving skills
• Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
• Effective collaboration and communication skills
• Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC, and ANOVA
• Experience with SolidWorks, other CAD-based programs, Minitab, R, and other statistical software
• Six Sigma/Design for Six Sigma experience, and/or knowledge of Process Excellence tools
• Leverage Lean manufacturing experience
• Knowledge of Quality and operations systems and processes, including GMP

Skills

• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
• Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
• Effective collaboration and communication skills
• Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC, and ANOVA
• Experience with SolidWorks, other CAD-based programs, Minitab, R, and other statistical software
• Six Sigma/Design for Six Sigma experience, and/or knowledge of Process Excellence tools
• Leverage Lean manufacturing experience
• Knowledge of Quality and operations systems and processes, including GMP

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Benefits include:

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year