STAFF QUALITY SYSTEMS ANALYST Job in Jacksonville, Florida Us
Johnson Johnson Vision Care, a member of Johnson Johnson's Family of Companies, is recruiting for a Sr. Quality Analyst located in Jacksonville, FL.
Transforming the world's vision, Johnson Johnson Vision Care, Inc. manufactures ACUVUE brand contact lenses - the world's first soft disposable contact lens. Johnson Johnson Vision Care is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Since our inception, we have strived to increase awareness of the importance of vision care and to provide the world's most exceptional vision correction options. Through our passion for innovation and our unwavering commitment to the highest standards of quality, we have become a world leader in vision care, providing a family of outstanding contact lens products. Research, innovation and new-product development are the focus of our organization and over half our sales come from products we have launched in the past 5 years.
The Staff Quality Systems Analyst will represent franchise in MDD sector QS initiatives. Integrate MDD standards (requirements) within the franchise Quality System. Lead QS design, development, deployment across the franchise (i.e., SIPOC, stakeholder analysis, business case development, stakeholder buy-in, project planning, deployment strategies, VOC, Value stream maps, resource planning allocation, systems/user requirements, business process flows, etc.). Partner with IT by providing the systems/user requirements, business process flows, user acceptance test strategy, global end-user alignment, etc. Review and approve changes to Quality System procedures. Support Compliance related (audit) activities.
Qualifications
Bachelors Degree - Scientific Discipline preferred or equivalent related experience (RAC certification, ASQ - CQA, CQE, or CSQE, ISO Lead Assessor). 8+ years of business experience with 4+ years of working experience in the quality assurance / quality systems/ compliance audit environment is required. Ability to effectively manage people (directly OR indirectly) and manage projects that include cross-functional teams representing diversified areas. Expert knowledge and understanding of Quality Systems regulated by domestic and foreign governments. Excellent understanding and application of principles, concepts, and practices of Quality Systems design, development, and deployment (to include QS IT solutions - system requirements, business process flows, user acceptance test strategy, etc.). Understanding and knowledge of a broad set of regulations and standards (21 CFR 820 required; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, etc). Ability to travel 10% is required. Medical Device experience is required. Previous experience managing people is preferred. Previous Project Management experience or PM certification preferred. Experience in the use of Process Excellence tools or PE certification is preferred. Experience in SDLC/GAMP is preferred.