Staff Quality Engineer, Market Quality (1 of 2)-9027140416
Description
VISTAKON®, a division of Johnson & Johnson Vision Care, Inc., a member of the Johnson & Johnson family of companies, is recruiting for a Staff Quality Engineer, Market Quality to be located in Jacksonville, Florida.
VISTAKON®, a division of 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. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUE® family of products. Our associates around the world are committed to expanding the ACUVUE® brand, and fortifying our position as the worldwide leader in the contact lens industry.
The Staff Quality Engineer, Market Quality will be responsible for the preparation, hosting and logistical planning for regulatory compliance audits of the Market Companies. Serves as company representative during such audits, facilitating all communications, facility touring, information requests, and corrective action/remediation plans as necessary. Responsible for the management and timely completion of audit actions resulting from the regulatory compliance audits. Responsible for tracking regulatory compliance trends and audit action related metrics such as timeliness and aging. In accordance with defined procedures and regional schedules, support regional Market Company internal and supplier audits. Ensure proper reporting, response review and approvals, communication of issues, and use of tracking and trending tools. As appropriate escalation of key issues to top management. Leads Quality and Compliance projects as needed. Develops and maintains key quality and compliance performance metrics. Participates in developing and presenting departmental materials for Management review. Promotes a culture of Regulatory Compliance and Risk Management throughout the organization. Supports departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures. Coordinates JJRC Audit program include preparation, hosting, and follow-up activities. Conducts internal and supplier quality system audits and follow-up activities. Assists project teams with identification of quality system requirements to ensure compliance. Acts as liaison with external auditors during third party audits. Monitors regulatory agencies for changes in requirements and evaluates impact to the organization. Performs other related duties as assigned by management.
Qualifications
To be considered for the role a minimum of a Bachelor’s Degree is required. A minimum of 7 years of professional experience in quality assurance / compliance, specific to working in a GMP environment is required, preferably in Medical Devices, Pharmaceutical, Consumer, or regulated healthcare industries. Experience managing regulatory compliance audits is required. Lead auditor certification (ASQ, BSI, etc.) is preferred. Project management experience including global cross functional projects is required. Experience implementing and deploying new processes and/or systems is required. Experience with multiple, global quality systems such as purchasing controls, audits, CAPA, non-conformance, change control, document control, training, and records management. Experience with process validation is preferred. Strong communication, organizational, negotiation and interpersonal skills. Expert knowledge, understanding and application of audit principles, concepts and practices related to regulated quality systems. Understanding and knowledge of a broad set of regulations and standards (e.g. 21 CFR 820; 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.)
This position will be located in Jacksonville, FL and will require the ability to travel up to 50% internationally.
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Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)
Travel:Yes, 50 % of the Time
Job Function: Quality (Eng)
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