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Staff Field Quality Post-Market Surveillance Engineer-9341140119
Description
The Ethicon Surgical Care business, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Field Quality Post-Market Surveillance Engineer. The preferred location for this position is Cincinnati, OH; however can also be located at any Ethicon Surgical Care site.
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 Staff Field Quality Post-Market Surveillance Engineer is responsible for addressing product complaint events (domestic and international) that directly impact retaining and fostering new business. The individual will provide training to enhance sales and marketing’s (failure mode) technical product knowledge. He/she will provide sales and marketing with tools and information to eliminate and/or minimize customer complaints by means of a technically based in-service. The Staff Field Quality PMS Engineer will identify and replicate product failure modes to reduce product complaints and identify and address compliance issues. The individual will develop customer based educational training materials. He/she will attend the Mechanical and Endoscopic CAPA meetings and support the CAPA process and participate in the HHE process upon request, as well as support Risk Management with product specific technical and compliance expertise.
The Staff Field Quality Post-Market Surveillance Engineer will maintain alertness to changes within EES that impacts the end use of EES products. The individual will review and make recommendations for improving Product Instructions For Use. He/she will act as primary and/or secondary general issues technical resource and contact for Complaint Management, Sales/Marketing domestic and international. The Staff Field Quality PMS Engineer will serve as a product expert supporting EES during times of interaction with government and regulatory agencies as required. The individual will make hospital visits to analyze and photograph product pending potential litigation, as well as make customer visits to observe surgical procedures and investigate potential product /user issues. He/she will meet with and serve as a technical resource to EES legal council as required. The Staff Field Quality PMS Engineer will analyze and document findings based on review of complaint related X-rays, DVD and CD submissions and develop an educational plan to meet the goals (eliminate complaints and improve customer service) of Customer Quality Complaint Management (CQCM) and Sales and Marketing – serve as an educational partner with EES Professional Education determining what educational activities will achieve desired goals and maximize return on investment. The individual will serve as the single point of contact for CQCM failure mode educational activities. He/she will develop and present innovative demo techniques that replicate voice of the customer issues to give practical meaning to product limitations that enhance customer satisfaction. The Staff Field Quality PMS Engineer will develop and present training materials for EES products that can be used globally as well as internal as a tool to increase the knowledge of product use for key customers, Sales/Marketing, CQCM Liaisons and Call Center Nurses. The individual will develop a means of obtaining feedback to ensure training is meeting customer needs and capturing improvement suggestions, as well as develop customized training programs to meet the needs of our surgical customers. He/she will actively participate by developing and presenting at both Delta V and RN Champs sponsored events. The Staff Field Quality PMS Engineer will make hospital and analysis site visits to investigate product usage performance for specific product events and disseminate feedback to appropriate management levels to include findings and recommendations that would enhance and/or deter future negative events. The individual will act as a liaison for communicating the voice of the customer to the appropriate internal departments and provide support and expertise relative to similar product voice of the customer issues for new product development. He/she will support field sales organizations (domestic and international) on highly technical product inquiries; providing appropriate product information, including technical and statistical data and work closely with sales and marketing globally to develop and deliver educational programs for targeted accounts; designed to maintain, convert and grow the business.
In addition to the above responsibilities, the Staff Field Quality PMS Engineer will use measurement systems to monitor effectiveness of training to identify. Bracket, correct and prevent product complaints related to improper use, to demonstrate improvements made to management. The individual will partner with R&D to maintain a high level of technical knowledge relative to newly released products as well new products in concept through release phases of development. He/she will conduct and/or support presentations for EES friendly key customer visits. The Staff Field Quality PMS Engineer does research or gathers information that anticipates and prevents problems and issues. The individual should be able to challenge the team and product design to improve the risk management situation (mitigate residual risk); can cascade risk to all appropriate parties for implementation and mitigation, as well as collaborate with Field Marketing and Professional Education or other internal and affiliate partners to ensure aligned objectives and maximize use of resources for optimal delivery of educational activities. In a conflict, he/she will express own position or opinions clearly and confidently to management and other key stakeholders. The Staff Field Quality PMS Engineer will conduct and/or support presentations for EES non-friendly key customer visits.
Qualifications
A minimum of a Bachelors degree is required. A degree in Engineering or a related technical field is preferred. 7+ years experience in a regulated industry is required. Experience within the medical device area is preferred. Experience in auditing for compliance to ISO or GMP standards is preferred. An understanding of anatomy and surgical procedures is preferred. Previous experience communicating with surgeons and/or other medical surgical professionals is preferred. Up to 15% travel, including international, may be required.
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-Ohio-Cincinnati
Other Locations:North America-United States-New Mexico-Albuquerque, North America-United States-New Jersey-Somerville
Organization: Ethicon Endo Surgery Inc (6041)
Job: Quality (Eng)
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.
Staff Field Quality Post-Market Surveillance Engineer-9341140119
Description
The Ethicon Surgical Care business, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Field Quality Post-Market Surveillance Engineer. The preferred location for this position is Cincinnati, OH; however can also be located at any Ethicon Surgical Care site.
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 Staff Field Quality Post-Market Surveillance Engineer is responsible for addressing product complaint events (domestic and international) that directly impact retaining and fostering new business. The individual will provide training to enhance sales and marketing’s (failure mode) technical product knowledge. He/she will provide sales and marketing with tools and information to eliminate and/or minimize customer complaints by means of a technically based in-service. The Staff Field Quality PMS Engineer will identify and replicate product failure modes to reduce product complaints and identify and address compliance issues. The individual will develop customer based educational training materials. He/she will attend the Mechanical and Endoscopic CAPA meetings and support the CAPA process and participate in the HHE process upon request, as well as support Risk Management with product specific technical and compliance expertise.
The Staff Field Quality Post-Market Surveillance Engineer will maintain alertness to changes within EES that impacts the end use of EES products. The individual will review and make recommendations for improving Product Instructions For Use. He/she will act as primary and/or secondary general issues technical resource and contact for Complaint Management, Sales/Marketing domestic and international. The Staff Field Quality PMS Engineer will serve as a product expert supporting EES during times of interaction with government and regulatory agencies as required. The individual will make hospital visits to analyze and photograph product pending potential litigation, as well as make customer visits to observe surgical procedures and investigate potential product /user issues. He/she will meet with and serve as a technical resource to EES legal council as required. The Staff Field Quality PMS Engineer will analyze and document findings based on review of complaint related X-rays, DVD and CD submissions and develop an educational plan to meet the goals (eliminate complaints and improve customer service) of Customer Quality Complaint Management (CQCM) and Sales and Marketing – serve as an educational partner with EES Professional Education determining what educational activities will achieve desired goals and maximize return on investment. The individual will serve as the single point of contact for CQCM failure mode educational activities. He/she will develop and present innovative demo techniques that replicate voice of the customer issues to give practical meaning to product limitations that enhance customer satisfaction. The Staff Field Quality PMS Engineer will develop and present training materials for EES products that can be used globally as well as internal as a tool to increase the knowledge of product use for key customers, Sales/Marketing, CQCM Liaisons and Call Center Nurses. The individual will develop a means of obtaining feedback to ensure training is meeting customer needs and capturing improvement suggestions, as well as develop customized training programs to meet the needs of our surgical customers. He/she will actively participate by developing and presenting at both Delta V and RN Champs sponsored events. The Staff Field Quality PMS Engineer will make hospital and analysis site visits to investigate product usage performance for specific product events and disseminate feedback to appropriate management levels to include findings and recommendations that would enhance and/or deter future negative events. The individual will act as a liaison for communicating the voice of the customer to the appropriate internal departments and provide support and expertise relative to similar product voice of the customer issues for new product development. He/she will support field sales organizations (domestic and international) on highly technical product inquiries; providing appropriate product information, including technical and statistical data and work closely with sales and marketing globally to develop and deliver educational programs for targeted accounts; designed to maintain, convert and grow the business.
In addition to the above responsibilities, the Staff Field Quality PMS Engineer will use measurement systems to monitor effectiveness of training to identify. Bracket, correct and prevent product complaints related to improper use, to demonstrate improvements made to management. The individual will partner with R&D to maintain a high level of technical knowledge relative to newly released products as well new products in concept through release phases of development. He/she will conduct and/or support presentations for EES friendly key customer visits. The Staff Field Quality PMS Engineer does research or gathers information that anticipates and prevents problems and issues. The individual should be able to challenge the team and product design to improve the risk management situation (mitigate residual risk); can cascade risk to all appropriate parties for implementation and mitigation, as well as collaborate with Field Marketing and Professional Education or other internal and affiliate partners to ensure aligned objectives and maximize use of resources for optimal delivery of educational activities. In a conflict, he/she will express own position or opinions clearly and confidently to management and other key stakeholders. The Staff Field Quality PMS Engineer will conduct and/or support presentations for EES non-friendly key customer visits.
Qualifications
A minimum of a Bachelors degree is required. A degree in Engineering or a related technical field is preferred. 7+ years experience in a regulated industry is required. Experience within the medical device area is preferred. Experience in auditing for compliance to ISO or GMP standards is preferred. An understanding of anatomy and surgical procedures is preferred. Previous experience communicating with surgeons and/or other medical surgical professionals is preferred. Up to 15% travel, including international, may be required.
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-Ohio-Cincinnati
Other Locations:North America-United States-New Mexico-Albuquerque, North America-United States-New Jersey-Somerville
Organization: Ethicon Endo Surgery Inc (6041)
Job: Quality (Eng)
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.