Senior Quality Engineer NPD

About the role

The Senior Quality Engineer plays a crucial role in ensuring the quality of Johnson & Johnson's products through various activities including new product development, engineering projects, and quality assurance.

Responsibilities

• Collaborate with other functional groups to support new product development, engineering projects, and quality assurance activities.
• Utilize Quality Engineering tools and processes to develop and implement practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Oversight of the 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, and engineering change orders.
• Perform statistical analysis of data using tools like Six Sigma, SPC, DOE, etc., to ensure process capability.
• Ensure development activities comply with design control requirements, product testing meets applicable standards, and manufacturing specifications are met.
• Conduct technical problem solving, failure analysis, and root cause determination.
• Represent the organization in conferences to resolve important questions and plan and coordinate work.
• Recommend issue resolution to management for significant capability and compliance issues.
• Plan, develop, coordinate, and direct large important engineering projects or multiple smaller projects with many complex features.
• Carry out complex or novel assignments requiring the development of new or improved techniques or procedures.
• Assess the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• Communicate business-related issues or opportunities to the next level of management.
• Follow all Company guidelines related to Health, Safety, and Environmental practices.
• Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties as assigned.

Experience and Education

• Bachelor’s degree in engineering or a related scientific discipline, or a minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry.

Required Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations

• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations.
• Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments.
• Ability to apply project management skills to ensure fulfillment of new product development requirements.
• Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
• Knowledge of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC, and ANOVA.
• Six Sigma/Design for Six Sigma experience, and/or knowledge of Process Excellence tools.
• Leverage of Lean manufacturing experience.
• Understanding of Quality and operations systems and processes, including GMP.
• Working knowledge of CAD software (Solidworks, AutoCAD).
• Experience with Minitab, R, and other statistical software.
• Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.

Preferred Skills

• Analytical Reasoning
• Coaching
• Customer Centricity
• Data Savvy
• Document Management
• Financial Competence
• Good Automated Manufacturing Practice (GAMP)
• Lean Supply Chain Management
• Process Improvements
• Quality Control Testing
• Quality Services
• Quality Standards
• Quality Systems Documentation
• Quality Validation
• Science, Technology, Engineering, and Math (STEM)

Pay Range

$79,000.00 - $127,650.00

Benefits

• Consolidated Retirement Plan (Pension)
• Savings Plan (401(k))
• Long-term incentive program
• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (State of Colorado: 48 hours; State of Washington: 56 hours)
• Holiday pay – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• 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