Quality Systems Analyst (Part Time - 34 hours/week)

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Quality Systems Analyst (Part Time - 34 hours/week)-7805130506

Description

Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Post-Market Surveillance Analyst (1 of 2), to be located in Somerville, New Jersey OR Cincinnati, Ohio.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading Legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Part-time Quality Systems Analyst will provide administrative support for the development, enhancement and maintenance of all franchise Quality and Regulatory Compliance (QRC) Product Lifecycle Management (PLM) applications, including but not limited to; ADAPTIV (Document/Change Management System), Non-Conformance Reporting (NCR)/Corrective and Preventive Action (CAPA) Systems, Learning/Training Management Software (Compliancewire), Global Audit Management (GAMS), Complaint Management System (Remetrex CHATS), Cognos/Lighthouse PLM reporting and Scorecards (QuID), and Excellence to Quality (ETQ).

This is a part-time position and will require the incumbent to work 34 hours per week.

Provide administrative support of multiple QRC PLM applications and associated processes.

Update and maintain system menu options.

Support system upgrades including functional process changes, additions, deletions etc.

Maintain user databases, access and profiles.

Support the development of, and directly maintain and update, associated procedures and documents.

Perform required user maintenance in PLM systems such as create/update/disable users, password resets, etc

Perform system troubleshooting and escalate issues for resolution as necessary.

Supporting the implementation and deployment of all QA PLM applications in partnership with IT and ITS, including Legacy system migration and other deployment activities based on business needs following J&J SDLC

Support associated validation/verification activities of all QRC applications

Support internal and external audits, as deemed necessary.

Assist in developing instructional training guides for users.

Assist in the performance of process and system training.

Support cross-functional linked teams to address business or system issues.

Perform miscellaneous job-related duties as assigned/Project Management tasks.

Facilitate and Implement yearly annual periodic review of user access for Quality System applications.

Qualifications

Minimum of an Associate's Degree and 1 year of systems administration experience working with systems in business, science, or technology required.

Experience working in a FDA-regulated or equivalent environment preferred.

Demonstrated experience with compliant, Product Lifecycle Management programs preferred.

Minimum of intermediate MS Office skills, including Excel, Word and Outlook required.

Strong computer skills including database management required.

Good communication and clerical skills required.

Must be able to interface with all levels of management and work as an integral part of a team.

BE VITAL in your career. Be seen for the talent you bring to your work.

Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)

Job: Compliance
Relocation: Eligible
No

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