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COMPLAINT ANALYST-0116140130
Description
Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Product Complaint Analyst, to be located in Somerville, NJ.
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 Product Complaint Analyst deals with internal and external customers on product complaints. Interfaces with external customers, sales representatives and international affiliates. Manages product complaints using the electronic system CHATS. Differentiates between product inquiry and product complaint and forwards to respective location for prompt customer service. Interfaces with electronic systems (e.g. CPAS, COACT, LIMS). Determines negative trends and enters product complaints into CPAS while identifying corrective/preventive action team. Makes MDR/MDV decisions for product complaints. Assists in providing analysis of trends and factors to Operations and technical staff management for resolution. Utilizes statistical tools to provide technical groups and sales/marketing groups with the appropriate information on field product quality. Provides timely process and response to external customer for closure or product complaint.
The Product Complaint Analyst provides support to Ethicon facilities during audits. Supports Project Manager or Managers on various projects. Accountable for all product complaints from inception to closure as well as corrective action follow-up. Works independently with minimal supervision. Supports safety and environmental initiatives.
Qualifications
A Bachelor's degree or Registered Nurse (RN) degree is required. A degree in a Scientific, Technical or Engineering field is preferred. Knowledge of statistical applications and auditing practices is preferred. General computer literacy, including proficiency in Microsoft Office, databases, and systems is required. Medical Devices/diagnostics and/or other regulated industry experience is preferred.
Competency in MDR and Vigilance regulations, medical knowledge, liability law, product use, product complaint and inquiry processes, and submission practices is preferred. General competency in QSR/ISO knowledge is preferred. Product/process knowledge is preferred. Good written and oral communication skills are required. Strong customer service orientation is required. Knowledge of existing quality systems is preferred. Ability to handle multiple priorities is required. This individual must respect confidentiality. This position is located in Somerville, NJ.
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
Organization: Ethicon Inc. (6045)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
COMPLAINT ANALYST-0116140130
Description
Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Product Complaint Analyst, to be located in Somerville, NJ.
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 Product Complaint Analyst deals with internal and external customers on product complaints. Interfaces with external customers, sales representatives and international affiliates. Manages product complaints using the electronic system CHATS. Differentiates between product inquiry and product complaint and forwards to respective location for prompt customer service. Interfaces with electronic systems (e.g. CPAS, COACT, LIMS). Determines negative trends and enters product complaints into CPAS while identifying corrective/preventive action team. Makes MDR/MDV decisions for product complaints. Assists in providing analysis of trends and factors to Operations and technical staff management for resolution. Utilizes statistical tools to provide technical groups and sales/marketing groups with the appropriate information on field product quality. Provides timely process and response to external customer for closure or product complaint.
The Product Complaint Analyst provides support to Ethicon facilities during audits. Supports Project Manager or Managers on various projects. Accountable for all product complaints from inception to closure as well as corrective action follow-up. Works independently with minimal supervision. Supports safety and environmental initiatives.
Qualifications
A Bachelor's degree or Registered Nurse (RN) degree is required. A degree in a Scientific, Technical or Engineering field is preferred. Knowledge of statistical applications and auditing practices is preferred. General computer literacy, including proficiency in Microsoft Office, databases, and systems is required. Medical Devices/diagnostics and/or other regulated industry experience is preferred.
Competency in MDR and Vigilance regulations, medical knowledge, liability law, product use, product complaint and inquiry processes, and submission practices is preferred. General competency in QSR/ISO knowledge is preferred. Product/process knowledge is preferred. Good written and oral communication skills are required. Strong customer service orientation is required. Knowledge of existing quality systems is preferred. Ability to handle multiple priorities is required. This individual must respect confidentiality. This position is located in Somerville, NJ.
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
Organization: Ethicon Inc. (6045)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.