This job posting is anticipated to close on Apr 28 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
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:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Athens, Georgia, United States of America, Cornelia, Georgia, United States of AmericaJob Description:
We are searching for the best talent for a Quality Engineer to be in Cornelia, GA or Athens, GA.
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/medtech.
Purpose: Builds core initiatives for Quality Engineering schematics, detailed layouts, and subsequent comprehensive supply chain outputs, as well as associated key performance metrics, goals, and objectives. Works collaboratively with management to drive decisions regarding Quality Engineering methods to produce leading-edge customer-tailored engineering final deliverables. The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally. The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
You will be responsible for:
- Communicates internally, any Quality Engineering issues or concerns to the next management level.
- Reports Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
- Advances and manages critical Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements.
- Estimates simple process validations on current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.
- Prepares and reviews capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements.
- Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
- This job is salaried.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Develop, interpret and implement standard and non-standard sampling plans.
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements.
- Ensures effective quality strategies are created for the validation of test methods process and design.
Qualifications/Requirements:
- A minimum of a bachelor’s Degree, preferably in Engineering or related technical field.
- Generally, requires 0-2 years work experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- The ability to perform “hands on” troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
- Good technical understanding of manufacturing equipment and processes is required.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
- Demonstrated project management and project leadership abilities are preferred.
- Interpretation and application of the following standards and regulations: 21 CFR 820, 21 CFR 4, 21 CFR 11, ISO 13485, ISO 14971, SOR/98-282, 93/42/EES, RDC16/2013, Australia Therapeutic Goods (Medical Devices) Regulations, Ministry of Health, Labour, and Welfare of Japan: Ordinance No.169.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson and Johnson is committed to providing interview process that are inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
