Job Function: Quality
Job Sub Function: R&D/Scientific Quality
Job Category:Professional
All Job Posting Locations:Irving, Texas, United States of America
Job Description:J&J MedTech is recruiting for a
Senior 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, 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
The Senior 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 & RESPONSIBILITIESResponsibilities:
- Support launch and stabilize new product launches through concept, design, development, and steady-state processes.
- 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.
- Ensures effective quality strategies for validation, including the development and validation of appropriate test methods for product and process performance
- 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
- Supports investigation and resolution of health authority inquiries, partnering with cross function teams (including Post Market Surveillance, Complaint Handling Unit, Clinical and Medical Affairs and Medical Safety).
- Participates in risk management process including Application, Design, Process FMEA's and Risk Management plans and reports.
- Mentor and guide Primary Quality Engineers.
- Proactively engage and collaborate with partners in R&D, Medical Affairs, Medical Safety, Regulatory Affairs, Manufacturing, Operations Quality, and Marketing to drive consensus and resolve issues in a timely fashion.
- Participate in internal and external audits.
- 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 EDUCATIONRequired:
- A bachelor's degree in engineering, science, or related technical field from an accredited university.
- Minimum of 5 years of work experience in a regulated industry
- New product development and/or lifecycle management experience
- Prior experience in a Quality Engineering role.
- Experience participating in risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms is an asset.
- Knowledge of FDA requirements for design control of medical devices
- Previous work experience engaging in a team-based environment
Preferred:
- A relevant advanced degree
- Experience with Class III 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)
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Required Skills: Preferred Skills: 
