Johnson & Johnson MedTech · 6 hours ago
Quality Engineer
Raritan, NJ
Full-time
Onsite
Entry, Mid Level
$90K/yr - $122K/yr
2+ years expJohnson & Johnson MedTech is dedicated to healthcare innovation, aiming to improve patient outcomes through advanced medical solutions. The Quality Engineer will lead and support Quality Engineering activities related to Design Controls, Product & Process Validation, and Risk Management, ensuring the highest quality experiences for patients and customers.
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 MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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