HireDiversity

Somerville, NJ, US

POST-MARKET SURVEILLANCE STAFF QUALITY ENGINEER (1 of 2)-6313130104

Description

Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Post-Market Surveillance Staff Quality Engineer (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 PMS Staff Quality Engineer performs post-market safety and surveillance activities including trend analyses, signal assessments and investigations. Executes the PMS process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events. Utilizes the signal analysis and detection data generated by the analytics team to assess trends/issues and perform detailed investigations to confirm the identified event. Works with internal and external customers. Builds relationships with organizational partners that generate post-market data. Works independently with minimal supervision. Executes tasks, manages projects and implements critical procedural elements. Tasks assigned by Manager or Director of PMS. Provides leadership and mentoring to business teams on the PMS process.

The PMS Staff Quality Engineer evaluates Signal Analysis/Detection Data. Interfaces with the PMS data analytics team to review signal analysis and detection data focusing on trends, triggers and control limits in PMS data that represent a potential Safety Issue/Product Quality Event. Evaluates potential Safety Issues/Product Quality Events against all know PMS Data sets with the intent of confirming the issues/event. Leads Signal Assessment Investigations. Performs issue/event investigations to understand root cause, risk and impact. Interfaces with key business partners including R&D, Operations, Medical and Marketing to ensure a thorough investigation is completed. Investigations can include user interviews and customer visits to ensure rapid response to field safety issues.

The PMS Staff Quality Engineer interfaces with Product Escalation Group. Depending upon the nature of the identified safety issue/product quality event, this individual will be the key interface with the Product Escalation group to ensure all events are escalated in a timely manner and per procedure. Executes the PMS process with a primary focus on product performance, safety and efficacy. Interfaces with internal partners, mainly, R&D, Operations, Medical Affairs and Marketing. Interfaces with external partners including sales representatives. Interfaces with electronic systems (e.g. CAPA, CHATS, TRIM, ADAPTIV). Prepares and presents PMS data to management. Leads the investigation of confirmed product events in the field. Interfaces with the PQI/Escalation team to determine appropriate pathway for the investigation of field events. Interfaces with customers/users including site visits and trainings. Provides support to Ethicon facilities during audits, as needed. Supports Managers or Director on various projects. Works independently with minimal supervision.

Qualifications


A Bachelor's degree in a Scientific, Technical, Engineering, or related field is required. A minimum of 6 years of relevant experience is required. Knowledge of statistical applications (e.g. Minitab, SAS, etc) is required. Knowledge of MS Office (Excel, Word, etc) is required. Technical experience (e.g. systems, software programs, analytical research, etc) is required. Medical Devices/diagnostics and/or other regulated industry experience is required. Manufacturing experience is preferred. Prior experience in a customer facing role is an asset.

Up to approximately 20% international and domestic travel may be required. This position can be located in Somerville, New Jersey OR Cincinnati, Ohio.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

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