Principal Quality Systems Specialist

Johnson & Johnson   •  

Madison, WI

Industry: Biotech/Pharma


8 - 10 years

Posted 295 days ago

This job is no longer available.

You, the Principal Quality Systems Specialist will:

  • Serve as a Quality Systems subject matter expert, track and report action plan status/ completion as relates to quality systems improvement efforts.
  • Lead creation and modification of Quality System procedures, work instructions and related documentation.
  • Monitors and reports Quality Management System metrics to include supporting the Quality System Management Review.
  • Franchise site lead for CAPA and Non-conformance. Supports product issue assessments and Field Action support.
  • Works on complex investigations and coordinates technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, and subsequent closure of investigations.
  • Responsible for conducting training in Quality Systems Management principles to business partners and other functional areas.
  • Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
  • Facilitates technical innovations to enhance Quality Systems and support business goals.
  • Provides support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits).
  • Ensure and maintain a state of Quality System inspection readiness;
  • Provide direction on department audit findings and CAPAs;
  • Provide support to internal audits as well as serve as SME in responsible areas for internal and external audits;
  • Lead special quality projects 


  • A Bachelor’s degree and a minimum of 8 years of experience in Quality Engineering, Quality Systems, Quality Assurance or Regulatory Compliance is required.
  • A degree in Math, science or engineering or business discipline (Management Science, Operations Research, Business Administration, or Software) and/or an advanced degree is preferred.
  • Experience in an FDA regulated industry (medical device, pharmaceutical, etc.) is preferred.
  • Working knowledge of 21 CFR Part 820, ISO 13485 is required.
  • Working knowledge of EU regulatory requirements are required.
  • Technical knowledge and experience to work effectively with others in diverse areas of business (Operations, R&D, R.A, Field Service, Finance, Marketing/Sales), is preferred.
  • Experience using MS Project, including preparation of critical path analysis and Gantt charts, is preferred.
  • Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.) is preferred
  • Ability to effectively prioritize and lead multiple activities and responsibilities is required.
  • Proficiency with quality-related applications such as those for MiniTab, Statgraphics, QI Macros, etc. is preferred
  • Background in developing, customizing and/or implementing inter-relational database applications, especially for project tracking or facilitating virtual work groups (SQL, Cognos, Access, Sharepoint, etc.), is preferred
  • American Society for Quality (ASQ) CQE, CQA, CMQ/OE, CSSGBB, CSSBB, or equivalent professional credential is preferred
  • This position will be located in Madison, WI and may require up to 15% domestic and/or international travel may be required.

Requisition ID: 2124180130