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 Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Athens, Georgia, United States of America, Cornelia, Georgia, United States of America

Job Description:

We are searching for the best talent for a Staff Quality Engineer to be located in Cornelia, GA and 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:

The Staff Quality Engineer is a seasoned individual contributor in a scientific/technology field. Conducts 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 Staff Engineer devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. The staff engineer is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods.

The Staff 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 and supervise or lead technicians. Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.

You will be responsible for:

• Constructs critical Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements.
• Coaches team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Oversees, under general direction, capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements.
• Confers with team members on process validations for current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.
• Assist in establishing ongoing training of Quality Engineering Technicians, supporting and enforcing site-specific safety and industrial hygiene requirements.
• Ensures timely escalation of any Quality Engineering issues or concerns to the next management level.
• Coaches more junior colleagues in techniques, processes, and responsibilities.​
• Identified quality issues are escalated for immediate resolution and work effectively with CAPA site leaders to ensure that these are escalated to CAPA accordingly.
• Maintain regular interface with site management to achieve company goals and escalate any issue related to NCs in terms of trend, resolution or resolution regarding NC process.
• Participate as requires in Audits and Management Reviews.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Qualifications/Requirements:

• A minimum of a bachelor’s Degree, preferably in Engineering or related technical field; advanced degree is preferred.
• Generally, Requires 4-6 Years Work Experience.
• Minimum 5 years’ experience in Operations, Engineering and/or Quality Assurance is required.
• Background in Medical Device Industry, preferred.
• Experience leading CAPAs is an asset.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Knowledge of regulatory requirements (ISO, QSR, etc.), preferred.
• Experience with external auditing bodies, preferred.
• Process Excellence Green Belt Certification with demonstrated problem-solving and statistics skills, preferred.
• Demonstrated project management skills with strong results orientation, 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.
• Strong communication, influencing and presentation skills, required.
• Physical Demands: Normal office environment, mental efforts.
• Work Environment: Frequent travel, Flexible to work on different shifts.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.