New Product Quality Engineer II

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Jacksonville, Florida, United States of America

Job Description:

We are searching for the best talent to join our Vision team as a New Product Quality Engineer II, to be located in Jacksonville, Florida.

About MedTech

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 ;br>
Key Responsibilities:

The New Product Quality Engineer (Engineer II) ensures that new products are safe, effective, and compliant with applicable regulatory standards (e.g. ISO 13485) from early-stage R&D concepts to transfer to manufacturing and ultimately, product launch.

To that end, as part of a cross-functional team, the New Product QE performs the following quality and technical functions associated with new ophthalmic product development:

• Research and Development: Supports early technology research by participating as the Quality Assurance representative in evaluating product design and material concepts, test methods, manufacturing processes, preliminary hazard analysis, and clinical risk assessments. Key contributor in the creation and maintenance of technology research plan documentation including product testing and clinical build protocols.

• Design Controls and Risk Management: Guides project teams through Quality system requirements around the creation, review, and documentation of product Design Control and Risk Mitigation deliverables.

• Design Verification and Validation: Key contributor in the development, review, and execution of protocols for design verification and validation to ensure the product meets user needs and intended use.

• Process Validation (IQ/OQ/PQ): Actively supports qualification projects preparing risk assessments, protocols, reports, test scripts, and test reports to qualify production lines to manufacture the product at scale.

• Documentation and Compliance: Works to create, review, approve and archive technical documentation associated with the product development process including the Design History File (DHF) and the Medical Device File (MDF)

• Life Cycle Management (LCM): Serves as the Quality lead for pre- and post-launch product design changes to ensure the design intent of the product is maintained through the product life cycle.

• Safety and Environmental: Adheres to company safety and environmental policies and procedures and supports department safety and environmental objectives.

Qualifications

Education:

• Bachelor's or equivalent university degree in Mathematics, Statistics, Engineering or Science is required

Experience and Skills:

Required:

• A minimum of 2 years working experience in the medical device industry
• Strong oral and written communication, interpersonal and organization skills
• Practical understanding and application of principles, concepts and practices of Design Controls and Risk Management

• General understanding of GMP/ISO medical device regulation and design verification / validation / qualification principles

Preferred:

• Working knowledge of Teamcenter (Siemens PLM)
• Working knowledge of Design of Experiments

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 Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:
Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy