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Principal Quality Systems Specialist
Requisition ID: 2124180130
NeuWave Medical, a division of Ethicon US, LLC, is seeking a Principal Quality Systems Specialist in Madison, WI.
NeuWave Medical specializes in developing and commercializing energy based, minimally invasive medical devices. We are an innovative growth company with a passion for clinical relevant, physician friendly technology and a commitment to improving patient outcomes.
You will provide high performance quality systems leadership for development, maintenance and enforcement of compliance with the company-wide quality management system.
You will lead projects and activities with business partners to provide leadership with regards to Quality System standardization and execution activities to ensure activities are compliant with J&J Enterprise Standards and external Standards and Regulations.
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.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
NeuWave Medical, Inc. (6229)