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