Principal Quality Engineer, Product Risk Management

☞ Johnson & Johnson

Ver: 120

Día de actualización: 11-11-2025

Ubicación: Beerse Antwerp

Categoría: Seguro de Calidad / Control de Calidad

Industria: Hospitals Health Care

Tipo de empleo: Full-time

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Contenido de trabajo

Description:

Janssen Supply Group a member of the Johnson & Johnson Family of Companies is recruiting for a Principal Quality Engineer Risk Management and Product Quality Management (PQM) Support! This position can be located in any of the J&J Innovative Medicine site such as Titusville, NJ, Horsham, PA, Beerse, Belgium and Leiden, Netherlands.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group is part of the Janssen Pharmaceutical Companies.

The Principal Quality Engineer is responsible for management, execution, and coordination of product risk management processes across functions for new product introduction and lifecycle management.

Key Responsibilities:

  • Lead and facilitate data driven product risk assessments to manage potential risk during development and commercialization
  • Own product risk management processes in PQM ensuring compliance and consistency with ICH Q9 and ISO 14971 risk management principles
  • Serve as process SME: Resolve process execution challenges through collaboration with internal customers, own relevant CAPA and change controls, provide education to users of the process
  • Makes a positive contribution through collaboration to identify, lead, and participate in PQM operational improvement opportunities.
  • Builds trust with others and seeks to discuss difficult issues or concerns openly and respectfully
  • Drive alignment and efficiencies through building positive relationships across functions, to meet unified business objectives
  • Craft and maintain PQM knowledge management repository such as PQM SharePoint
  • Applies knowledge of project management tools to drive projects from start to completion and communicate the project status to project partners and sponsors
  • Engage in global councils/ enterprise forums, ensuring product risk management business needs are represented
  • Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements
  • Other duties will be assigned, as necessary

Qualifications:

Education:

  • A University Bachelor’s degree, or equivalent, is required with a focus in engineering, science, or relevant technical subject preferred.

Experience and Skills:

Required:

  • A minimum of 8 years of related experience in pharmaceutical, biotech, or medical device industry
  • A minimum of 1 year of Product Risk Management experience specifically in pharmaceutical or med tech
  • Experience in application of risk assessment methodologies
  • Knowledge of risk management principles including ISO 14971 and ICH Q9, and cGMP regulations
  • Good organizational, planning and prioritization skills; excellent written and verbal communication skills

Preferred:

  • An individual with strong interpersonal skills who can communicate effectively with partners across different levels of our organization
  • Experience crafting and delivering training across functions

Other:

  • Must be proficient in the English language (speak, read & write).
  • This position may require up to 10% domestic & international travel.
  • The salary for this position, if based in the US, is anticipated to be between $95,000 to $155,000

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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Plazo: 26-12-2025

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