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

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Johnson & Johnson, Vision is recruiting for a Quality Engineer, to be located in Jacksonville, FL. This position is not remote.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

The Quality Engineer is responsible for coordinating assignments related to entire QA projects or specific components of large projects. They identify the methods and techniques to employ or adapt existing methods to address variations. This role involves coordinating work phases with both internal teams and external partners.

The Quality Engineer will apply Quality Engineering tools and methodologies to ensure the effective and efficient development, transfer, and maintenance of products and processes across their lifecycle. The individual will also implement Quality Engineering principles and employ problem-solving skills to enhance and sustain products and processes in line with the overall Quality and Business objectives.

Additionally, they will employ suitable risk management practices and compliance to avert unexpected failure modes and enhance process capabilities. This position will also support processes within the base business operations.

Furthermore, the Quality Engineer will adhere to environmental policies and procedures while championing departmental environmental goals.

Key Responsibilities:

Business Improvements

• Assist in quality improvement initiatives, including process and product characterizations, aimed at achieving continuous and cost-effective enhancements.
• Evaluate and analyze the effectiveness of methodologies such as Six Sigma, Kaizen, Lean Techniques, and other improvement tools and programs.
• Perform benchmarking to identify more effective strategies for enhancing quality.
• Give to the development of quality engineering and compliance through various departments.

Compliance/Regulatory

• Review/analyze whether current products and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.
• Champions compliance with applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Review results of area audits to ensure that corrective and preventive actions are adequate.

New Product/Process Introduction

• Partners with R& D and other multi-functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports new product introduction as part of design transfer as needed.

People

• Provides mentoring and coaching, for others

Product Quality, Control, and Disposition and Performance Standards

• Supports activities related to Escalations and Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.
• 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.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics include maintenance and reviewing of leading and lagging indicators of quality.

Production/Process Controls

• 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 as part of the nonconformance process.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and implement/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

Risk Mitigation

• Document, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs.
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

Education:

• Minimum of a Bachelor’s degree, preferably in Engineering or related technical field.

Experience and Skills:

Required:

• 2-4 years of related experience required.
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of FDA and ISO standards is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Good technical understanding of manufacturing equipment and processes is required.
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.

Preferred:

• Experience working in both an FDA and European regulatory environment is preferred.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies are preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• 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.

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.