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Engineer III, Product Quality Vigilance Investigation Support (PQVIS)
Company: Johnson & Johnson
Location: Malvern, PA
Employment Type: Full Time
Date Posted: 09/11/2021
Expire Date: 11/10/2021
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Customer Service and Call Center, Engineering, Healthcare, Practitioner and Technician, Information Technology, Manufacturing and Production, Quality Control, Medical
Job Description
Engineer III, Product Quality Vigilance Investigation Support (PQVIS)

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Engineer III, Product Quality Vigilance Investigation Support (PQVIS)! This position will be based in one of our Janssen Supply Group facilities within the United States.


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, LLC is part of the Janssen Pharmaceutical Companies.


Are you interested in joining a team that is helping improve patient and customer care and drive innovation? Apply today!


The PQVIS Engineer III will collaborate with business partners and stakeholders (Internal/External Manufacturing Sites, Clinical, PV, IT, Local Operating Companies, External Quality, Call Centers, Brand Protection, Business Quality, Medical Safety and R&D) to ensure complete and holistic investigations for PQCs, evaluating information from technical and quality compliance perspectives to ensure appropriate analysis and investigation in accordance with regulations and standard operating procedures. They will support the process of submissions of Medical Device Reports and manage appropriate Corrective/Preventive actions related to PQC Investigations. Additionally, they are responsible for supporting assigned Health Authority inspections, supporting various projects within the department, and communicating effectively will all levels of management.


Key Responsibilities:

  • PQV SMEs for investigations, driving consistency to global procedures and alignment of investigations across Janssen sites (internal/external) and Local Operating Companies (LOCs).
  • Partner with manufacturing sites and business partners to drive prioritization.
  • Support escalations and proactive identification of emerging product issues, with attention to potential impact to open and/or future complaint issues.
  • Collaborate with manufacturing sites and business partners to lead active monitoring and evaluation of lot signals and trends associated with Janssen products.
  • Provide audit and inspection support for Janssen sites and LOCs scheduled with impact to the Janssen product portfolio of products.
  • Drive business partner engagement and communication efforts with Janssen sites and LOCs when applicable.


Skills and Experience:


  • Minimum of a Bachelor's degree and 4 years of relevant work experience -OR- minimum of an Associate's degree and 6 years of relevant work experience is required; advanced degree or focused degree in Technical, Scientific, or Engineering subject areas preferred
  • Quality Assurance and/or Quality Control experience
  • Pharmaceutical, Medical Device, or other related highly regulated industry experience


  • Experience in Complaint Management, Post Market Vigilance, Risk Management and/or Compliance
  • Global mentality and demonstrated ability for change initiatives, project management, and developing strong, positive relationships
  • Solid understanding and working knowledge/experience with the following regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ISO 13485:2003, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR and/or the Medical Device Directive 93/42/EEC
  • Demonstrated written and verbal communication skills, both technical and persuasive, and the ability to present effectively to multiple levels and departments within the organization
  • Six Sigma (Green or Black Belt) or CQE (ASQ) certification


  • Requires up to 10% travel, domestic and international


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.

Primary Location
United States-Pennsylvania-Horsham-200 Tournament Drive
Other Locations
North America-United States, North America-United States-Puerto Rico-Gurabo, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern
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