Quality Engineer, Vision

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:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

We are searching for the best talent for Quality Engineer to join our Vision Care team located in Jacksonville, FL.

About Vision

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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. The Quality Engineer will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.

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 and adheres to environmental policy, procedures, and supports department environmental objectives.

Key Responsibilities:

• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• 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 including maintenance and reviewing of leading and lagging indicators of quality.
• Attend daily value stream meeting with internal partners and ensure support of OPP.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• 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.
   

Qualifications

Education:

• A minimum of a Bachelor’s Degree, preferably in Scientific Discipline, Engineering, Computer Science, Chemistry, Biology, or related field.
   

Experience and Skills:

Required:

• 0-4 years of experience in a regulated environment.
• Experience working in regulated environment is helpful.
• Experience working in a manufacturing environment is helpful.
• Knowledge of product/process Risk Management (FDA and ISO standards) is required.
• The ability to perform "