Primary Quality Engineer NPI LCM

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

J&J MedTech is recruiting for a Primary Quality Engineer New Product Innovation & Lifecycle Management (NPI/LCM) to join our Aesthetics & Reconstruction (A&R) organization located in Irving Texas.

Fueled by innovation at the intersection of biology and technology were 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 Primary Quality Engineer NPI LCM is responsible for supporting product quality and reliability ensuring the implementation of ground-breaking technology for medical devices is safe effective and follows applicable regulations standards and industry practices. Working closely with multi-functional teams this individual will support product quality throughout the product lifecycle for both new product introductions and lifecycle management. The individual reviews and assesses development activities (e.g. user needs development / quality plans requirements risk management verification and validation) to ensure that they align with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA Complaints post market surveillance and both Internal & External Audits.

DUTIES & RESPONSIBILITIES

Responsibilities:

• Support launch and stabilize new product launches through concept design development and steady-state processes.
• With support from more experienced QE drives the development of product requirements verification strategies and validation strategies.
• Ensures new product development compliance to GMP (Good Manufacturing Practices) ISO (International Organization for Standardization) and any other applicable standards
• Activities would drive prevention detection of defects at earliest phase of product design continuous improvement & customer satisfaction.
• Proactively engage partners to drive consensus and resolve issues in a timely fashion.
• Provide statistical support and analytical problem solving for product development and manufacturing.
• Review and approve design control manufacturing quality engineering and validation / qualification documents for conformance business practices and departmental procedures.
• Develop inspection and sampling plans test methods and transfer functions for products and components
• Provide support in developing and executing a reliability strategy during new product development.
• Participates in risk management process including User Design and Process FMEAs.
• Conducts projects and assignments with technical responsibility based on mentorship from more senior QE.

• Proactively engage and collaborate with partners in R&D Lifecycle Management
• Participate in internal and external audits.
• Support global health authority requests.
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.
• Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION

Required:

• A Bachelors Degree in engineering science or related technical field from an accredited university.
• Minimum of 3 years of work experience in a regulated industry
• Prior experience in a Quality Engineering role.
• Previous work experience engaging in a team-based environment

Preferred:

• Relevant advanced degree
• Experience with Class III medical devices
• New product development and/or lifecycle management experience
• Knowledge of FDA requirements for design control of medical devices
• ASQ Certified Quality Engineer ASQ Certified Reliability Engineer and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV DMAIIC or Lean)
• Experience participating in risk management discussions particularly as it relates to cascading identified product issues/hazards into potential user harms is an asset.

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-Onsite

Required Skills:

Preferred Skills: