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Staff Engineer, Product Risk Management

Company: Disability Solutions
Location: Irvine
Posted on: June 7, 2024

Job Description:

Johnson & Johnson Surgical Vision Inc. a member of the Johnson & Johnson family of companies, is recruiting for a Staff Engineer, Product Risk Management, located in Irvine or Milpitas, California! 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 . In this role you will be part of the Johnson & Johnson Vision Lifecycle Management and New Product Introduction Quality Engineering team! You will have responsibilities in planning, implementing, execution, standardizing, coordinating, and managing Risk documentation for Surgical Vision products. This role is responsible for Vision products excluding Contact Lenses and CEH (Consumer Eye Health) solutions. Key Responsibilities:

  • Provides the ongoing maintenance of the Risk Management files for current marketed product in accordance with all applicable laws/regulations and Corporate Johnson & Johnson, procedures and guidelines.
  • Reviews and continuously leads efforts to improve the Risk Management System for products both pre and post launch.
  • Maintains dashboards and other reports of performance metrics as required while providing regular updates and status reports to management.
  • Initiates quality event escalations as appropriate when product risk profiles change and facilitates the generation of risk documents as part of the applicable design phase within the Product Development Process.
  • Participates in evaluation processes as the Quality Representative, approves regulatory reports for submission to US FDA as well as other regulatory bodies, drafts response communications to inquiries from regulators and supports internal/external audits and inspections defending risk management documentation.
  • Remains informed of new or revised regulations and/or guidelines and assesses impact on company Risk Management processes to maintain the Risk Management System in accordance with ISO14971 and all Enterprise, MedTech and Vision Standards.
  • The role requires interaction with the Complaints Management team and Post Marketing Surveillance Group to provide updates to risk documents as well as collaborating with multiple teams and other departments to ensure compliance with applicable risk standards.
  • Works to improve the systems used within the New Product Development community ensuring compliance to existing procedures and uniformity of risk assessments performed on new products.
  • Responsible for conducting business meetings with other functions and communicating business related issues or opportunities to next management level.

Keywords: Disability Solutions, Irvine , Staff Engineer, Product Risk Management, Engineering , Irvine, California

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