At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function: R&D Product Development
Job Sub Function: Biomedical Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Raritan, New Jersey, United States of America
Job Description:Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at
https://www.jnj.com/medtechWe are searching for the best talent for
Quality Engineer to be in Raritan, New Jersey
The Quality Engineer shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for the leadership and support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing. Wound Closure and Hearling is a market leader in surgical tissue healing with a broad portfolio including Antibacterial sutures, Knotless Tissue Control Devices, Topical Skin Adhesives, Skin Closure Systems, and traditional absorbable and non-absorbable surgical sutures with innovative needle technologies.
DUTIES & RESPONSIBILITIESIn accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position includes the following:
- 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
EXPERIENCE AND EDUCATION- A Bachelor's Degree is required in engineering, science or related technical field from an accredited school is required. A relevant advanced degree is preferred.
- A total of 2 - 4 years of work experience is expected. Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES andAFFILIATIONS- Knowledge of ISO13485 and/or cGMP regulations.
- An ASQ certification (CQE, CQM, CRE, or CQA), Six Sigma (Green Belt, Black Belt, etc.), or Process Excellence certification is preferred.
- 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.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via
https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:Preferred Skills: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
The anticipated base pay range for this position is :$90,100.00 - $121,900.00
Additional Description for Pay Transparency:
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. • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation - up to 120 hours per calendar year o 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 o 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 • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
