Staff Compliance Specialist

Company: J&J Family of Companies
Location: Milpitas
Posted on: April 10, 2021

Job Description:

Johnson & Johnson Surgical Vision, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for Staff Compliance Specialist! At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. Thats why, through our operating companies, weve developed solutions for every stage of lifeto help people see better, connect better and live better. We partner with eye care professionals to provide some of the worlds leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn. Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity. Are you interested in being a part of the good we're doing? Apply today! The Staff Regulatory Compliance Specialist is responsible for planning, coordinating, and conducting quality system audits and support activities for compliance to federal, international regulations, standards (e.g., FDA QSR, FDA cGMP, ISO, etc.) and Company requirements. This role is also responsible for providing support for FDA, Health Authority and Notified Body inspections conducted at J&J Vision locations, including readiness activities, front- and back-room participation/management and general inspection support as requested. Facilities include worldwide operations, including the United States, Europe, and Asia. Key Responsibilities: --- Provide support to the JJV segment in the performance of audits or audit related activities.--- Serve as company representative during regulatory inspections, including support activities such as actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.--- Provide regulatory assessments of internal/external audit findings. Review/monitor correction, corrective, preventive, and effectiveness actions.--- Promote a culture of proactive compliance to regulations, standards, and procedures and risk management throughout the organization.--- Develop and maintain key quality and compliance performance metrics. Participate in developing and presenting departmental materials for Management Review and other leadership forums. Qualifications Education: --- Minimum Bachelors degree required in a scientific or engineering discipline or equivalent field--- Certifications preferred in ASQ-CQA, CQE or SCQE, ISO Lead Assessor, and/or RAC Skills and Experience: Required: --- Minimum 6 years of relevant work experience--- Experience working in a quality assurance / compliance audit environment--- Experienced auditor in a Quality regulated environment--- Strong knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments--- Experience managing and implementing robust Corrective and Preventive Action Systems--- Strong communication, organizational, negotiation, and interpersonal skills, with the ability to work cross-functionally and influence change Preferred: --- Experience managing External Regulatory/Notified Body Inspections (e.g., FDA, ANVISA, PMDA, BSI, etc.)--- Understanding and knowledge of a broad set of regulations and standards (e.g., 21 CFR 820, ISO 13485, EU MDD/MDR, MDSAP, etc.) Other: --- Requires up to 10% travel, domestic and international 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. Primary Location United States-California-Milpitas-510 Cottonwood Dr. Organization Johnson & Johnson Surgical Vision, Inc (6234) Job Function Quality Requisition ID 2105888093W

Keywords: J&J Family of Companies, Milpitas , Staff Compliance Specialist, Other , Milpitas, California