Staff Compliance Specialist


Medical Devices Diagnostics Global Services, LLC, a division of the Johnson Johnson Family of Companies, is recruiting for a Staff Compliance Specialist. This position will be based at the Vision Care franchise in Jacksonville, Florida.

Medical Devices Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MDD organization supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.

Reporting to the Manager of Quality Operations Compliance, Vision Care, the Staff Compliance Specialist will: be responsible for co- hosting, where required with Franchise Compliance, the logistical planning for regulatory inspections with agencies such as the FDA, ISO, and State Department of Health; serve as the company representative during such audits, facilitating all communications, facility touring, information requests, and corrective action and/or remediation plans as necessary; establish and maintain regulatory inspection readiness plans at the manufacturing site; establish and maintain programs for the ongoing monitoring and improvement of the effectiveness of the Quality System; be responsible for the creation, deployment, and maintenance of the internal audit schedule and approved auditors list; be responsible for status updates and reporting on resource or schedule adherence challenges; ensure that audit procedures align with MDD expectations; perform required audits in accordance with defined procedures and the master schedule; ensure proper reporting, response review and approvals, communication of issues, and use of tracking and trending tools; escalate key issues to upper management as appropriate; lead Quality and Compliance projects such as new product launches; provide regulatory compliance guidance with regard to the following areas: medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions; develop and maintain key quality and compliance performance metrics; participate in developing and presenting departmental materials for Management Review and Annual Product Reviews; promote a culture of Regulatory Compliance and Risk Management throughout the organization; support departmental and franchise objectives while adhering to the values of the Johnson Johnson Credo and local safety and environmental policy and procedures; serve as a Subject Matter Expert when required to support proactive and reactive responses to issues; maintain the manufacturing site compliance dashboard for metric reporting; be responsible for EDGE Database, QSCAN and Compliance Dashboard reporting for the manufacturing site in support of the Supply Chain Quality Director; maintain a strong working relationship and partnership with Franchise Compliance and Supply Chain Quality Assurance and support Compliance initiatives where agreed; provides leadership, oversight and guidance for significant regulatory compliance issues in the manufacturing sites, EMs and Suppliers; source, support and manage contract resources where required to fulfill Manufacturing Site Compliance Requirements; coach and guide Quality System Auditors and support staff as required; influence day-to-day harmony within the group and recommend and support technical and process improvements.

Qualifications

A minimum of a Bachelors Degree or the equivalent related experience is required; a minimum of a Bachelors Degree in a scientific or engineering discipline is preferred; RAC certification, ASQ - CQA, CQE or SCQE, Qualified ISO Lead Assessor certification is preferred; a minimum of six (6) years of professional work experience within a quality assurance or compliance audit environment is required; a minimum of eight (8) years of professional work experience within a quality assurance or compliance audit environment is preferred; a demonstrated expert knowledge and understanding of the application of audit principles, concepts and practices related to quality systems regulated by domestic and foreign governments is required; prior experience managing and implementing robust Corrective and Preventive Action Systems is required; and prior experience managing External Regulatory and/or Notified Body Inspections (e.g. FDA, Anvisa, Florida DoH, BSi etc) is preferred; strong communication, organizational, negotiation and interpersonal skills are required. This position will require up to 25% international and domestic travel and will be based at the Vision Care franchise in Jacksonville, Florida.

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