Johnson & Johnson · 12 hours ago
Quality Engineer
Raritan, NJ
Full-time
Onsite
Entry, Mid Level
$90K/yr - $122K/yr
2+ years expJohnson & Johnson is a leader in healthcare innovation, striving to deliver breakthroughs that profoundly impact health for humanity. The Quality Engineer will be responsible for leading and supporting Quality Engineering activities related to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for Wound Closure and Healing products.
Hospital & Health Care
Responsibilities
Demonstrating growing proficiency in applying various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process and business improvements
Demonstrating growing proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure modes, and effects analysis)
Contributing to the reliability assessments of product design
Contributing to root cause investigations using various problem-solving techniques and tools and assesses the effectiveness of corrective actions
Supporting the development of test methods in equipment, process, and product qualifications/validations. Executing methods as needed for development and qualification
Implementing and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics)
Supporting execution of project plans as a contributing member of the team
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Qualification
Required
A Bachelor's Degree is required in engineering, science or related technical field from an accredited school is required
A total of 2 - 4 years of work experience is expected
Knowledge of ISO13485 and/or cGMP regulations
Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs)
The Quality Engineer is expected to continue growing and be able to function in the following technical quality areas with minimal input and mentoring
Applied statistics of increasing complexity
Expectations of regulated bodies: Design control, Good documentation practices, Good manufacturing practices Organizational requirements, Root cause analysis and Corrective Action / Preventive Action (CAPA) expectations
Perform Measurement System Analysis (MSA) and reliability testing/analysis under guidance
Personal computer skills, Windows: word processing, project planning, presentation, e-mail, and spreadsheet software
Learn and apply software packages, as required
Preferred
A relevant advanced degree is preferred
Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred
An ASQ certification (CQE, CQM, CRE, or CQA), Six Sigma (Green Belt, Black Belt, etc.), or Process Excellence certification is preferred
Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Data Reporting, Data Savvy, Design of Experiments (DOE), Detail-Oriented, Execution Focus, Feasibility Studies, Preclinical Research, Problem Solving, Process Oriented, Prototyping, Report Writing, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase