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For your reference, we have included the original job posting below.
Quality Systems & Compliance Specialist (1of 2)
Job Number:
41190986
Company Name:
Johnson & Johnson Family of Companies
Job Location:
Irving, TX US
Job Category:
Healthcare & Medical
Quality Systems & Compliance Specialist (1of 2)
Title: Quality Systems & Compliance Specialist (1of 2) Location: Texas-Irving Medical Devices & Diagnostics Global Services, LLC., Quality Organization is recruiting for a Quality Systems & Compliance Specialist to support the Mentor franchise. This position is located in Irving, Texas.
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 MD&D SC 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.
Mentor Worldwide L.L.C., is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
The Quality Systems & Compliance Specialist leads administration of quality system programs as assigned, such as internal audit program, records retention program, site external quality system standards & directives implementation program. Reports metrics performance to requirements for assigned quality system programs. Performs internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements. Assists with preparing for and conducting external audits & inspections, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion. Uses basic statistical methods, quality tools and computer generated reports to improve processes. Participates in quality system improvement initiatives. Serves as quality systems & compliance representative on assigned cross-functional teams to ensure appropriate quality system process controls are included into project deliveries as part of an efficient and effective Quality Management system. Ensures compliance of assigned systems & projects with the FDA Quality System Regulation, ISO13485 and other industry standards as applicable. Other duties as assigned. A High School diploma and a minimum of 5 years experience working in an FDA regulated environment is required. Medical Device manufacturing experience is preferred. Experience performing or supporting internal quality systems audits is preferred. The ability to read and understand general business periodicals and applicable standards such as ISO13485 and Quality System Regulation is required. Proficiency in the Microsoft Office suite of products is required. The ability to effectively work as part of a team while maintaining flexibility and strong attention to detail is required. Current quality certifications, such as Certified Quality Auditor (CQA), Certified Quality Technician (CQT), or other professional certification is preferred. This position is located in Irving, Texas.
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