Principal Quality Systems Specialist
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NeuWave Medical, Inc., a division of Ethicon, Inc., part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Principal Quality Systems Specialist located in Madison, Wisconsin.
NeuWave Medical®, founded by physicians and scientists, built the first intelligent ablation system and the only system that has it all. The versatile probe portfolio with multi-probe synchronized energy delivery allows physicians to tailor ablations. In addition, the 17-gauge Precision™ PR probe is the only probe available with distal energy control. The unrivaled computer-controlled system now includes Ablation Confirmation™ software, offering the only integrated in-procedure confirmation to evaluate the technical success of your procedure.
This meaningful position supports and handles the day-to-day operations of the Quality Systems staff. Coordinates the development and implementation of processes, procedures, audits and corrective actions and also ensures effective communication and training are deployed throughout the business.
• Serves as a Quality Systems subject matter expert, tracks and reports action plan status/completion as relates to quality systems improvement efforts
• Leads creation and modification of procedures, work instructions and related documentation.
• Monitors and reports Quality Management System metrics to include supporting the Quality System Management Review (QSMR)
• Will manage one direct report
• 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 partner and other functional areas.
• Sees opportunities to continuously improve and processes in alignment with overall quality and business objectives.
• Facilitates technical innovations to improve Quality Systems and support business goals.
• Provides back room support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits).
• Maintains a state of Quality System inspection readiness.
• Provides support to internal audits as well as serve as SME in responsible areas for internal and external audits;
• Leads special quality projects.
• Bachelor’s degree in math, science, engineering, business discipline (Management Science, Operation Research, Business Administration, or Software) or related required. Advanced degree preferred.
• Minimum 8 years work experience in Quality Engineering, Quality Systems, Quality Assurance and/or Regulatory Compliance in a regulated industry is required.
• Medical Device experience preferred.
• Experience using MS Project, including preparation of critical path analysis and Gantt chart preferred.
• Ability to prioritize and lead multiple activities and responsibilities is required.
• Ability to communicate potential issues and work with all levels within the organization is required.
• Background in developing, customizing and/or implementing inter-relational database applications, especially for project tracking or facilitating virtual work groups preferred (i.e., SQL, Cognos, Access, Encore, SharePoint, Wiki etc.)
• American Society for Quality (ASQ), CQE, CQA, CMQ/OE, RAC or equivalent professional credential preferred.
• Proficiency with quality-related applications such as those Minitab, Statgraphics, QI Macros, etc, is preferred.
• Project Management Certification (example: PMI Certification, Graduate Certification in Program Management, etc) is preferred
• People management experience and building teams to support business growth preferred
• Up to 10% travel may be required
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.
NeuWave Medical, Inc. (6229)