Johnson & Johnson companies are equal opportunity employers.
Product Safety Manager, Post Market Surveillance-8336140626
Description
Ethicon Endo Surgery is currently searching for a Product Safety Manager, Post Market Surveillance located in Somerville, NJ or Cincinnati, OH.
The Ethicon 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 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.
Key Job Responsibilities:
Managing Post Market Surveillance processes focused on worldwide product performance and safety signal detection, including direct supervision of PMS Analyst(s)/Engineer(s). Direct responsibility for PMS process for business units within Ethicon (including all businesses impacted by the Ethicon and EES Quality Systems) for both Somerville and Cincinnati Campuses. Managing the execution of the Post Market Surveillance processes for product trending, trending review meetings, data management, PMS Plans, PMS Reports, Complaint Support, and Regulatory Support. Supporting the business planning and data deep dive processes to drive continuous improvement through data evaluation and presentation. Acting as the main point of contact for data needs and investigation support for the all worldwide support functions as it relates to product performance and complaint investigation. Driving collaboration and cross functional teaming between QSRC, LCM, R&D, Supply Chain, Medical Safety, Medical Affairs and Customer Quality organizations to develop and sustain processes that deliver customer focused solutions to product performance opportunities. Provides backup to Post Market Surveillance Director when required. Coordinates the trending and monitoring of all complaint and customer related data and feedback to include the calculation of control limits, support of CAPA Council and/or monthly complaint trending. Manages the creation and maintenance of Post Market Surveillance Plans, including for new products and existing products. Manages the creation and timely exection of Post Market Surveillance Reports and the complaince to the approved plans. Drive continuous improvement by establishing and maintaining processes that identify and correlate product trends with internal data streams to include manufacturing data, product complaint analysis findings, complaint data, or other relevant data sources. Provides field product information to Marketing and R&D as part of the strategic initiative of prouct enhancements/improvements. Identifies and drives continuous improvement in the PMS and data management processes as it relates to prouduct performance and complaint information. Supports projects relating to new product introductions to ensure Post Market Surveillance planning have been represented in the process including appropraite VOC, AFC and complaint category identification. Acts as a consultant and provides leadership on Post Market Surveillance projects. Supports the communication of follow-up letters/inquiries regarding MDR product complaints with the FDA and MDV product complaints with the Competent Authority, Authorized Representatives and Regulatory Franchise Managers as needed. Assists in providing analysis of trends and factors to the supply chain, LCM and Technical staff management for resolution. Coordinates the Corporate Document Retention Policy for PMS. SAFETY: Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies and procedures. Evaluate staff member’s safety performance and insure that safety is a part of each direct report’s OGSMs. Provide resources (time and money) necessary to maintain safety process. Ensure safety structure is in place in form of working committees and department coordinators. Provide a consistent point of contact between the Quality, LCM, Supply Chain and R&D organizations to include support of any product performance initiatives. Develop & implement appropriate metrics to track & monitor performance. Provide leadership to organization to ensure that all processes and systems comply with established specifications & regulations. Complete & deliver performance reviews of direct reports, and establish associate performance and potential ratings. Contract with direct reports to develop viable development plans & objectives; facilitate, coach & manage associates through the development process. Participate in and support up to possibly running CAPA/Monthly Trending meetings. Other responsibilities may be assigned & not all responsibilities listed may be assigned.
Qualifications
A minimum of a Bachelor's degree in Scientific, Technical, Engineering, Nursing or a related discipline is required. An advanced degree and/or MBA are a plus. A minimum of 2+ years of supervisory/people management experience is required. A minimum of 5+ years of progressive experience within a regulated industry (Medical Device, Pharmaceutical, or Consumer Good) is required. A demonstrated successful integration of Quality Systems elements and their management is preferred. Ability to lead cross-functional teams, sometimes requiring managing and leading without authority is also required. The ability to lead in a complex matrixed environment is required. A Green Belt, Black Belt Certification, PE Leadership training from J&J, CQE (Quality Engineer Certification), CRE (Reliability Engineer Certification), CQA (Quality Auditor Certification), or CQM (Certified Quality Manager) are preferred. Ability to translate large sets of quality data into actionable statistical analysis is also required. Knowledge and/or experience with ISO 14971 are preferred. This position will be based in either Somerville, NJ or Cincinnati, OH and requires up to 40% domestic travel, with the potential for international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
J2W:RAPS
J2W: ASQ_Phil
J2W: ASQ_Princeton
J2W: ASME
Primary Location:North America-United States-New Jersey-Somerville
Other Locations:North America-United States-Ohio-Cincinnati
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Product Safety Manager, Post Market Surveillance-8336140626
Description
Ethicon Endo Surgery is currently searching for a Product Safety Manager, Post Market Surveillance located in Somerville, NJ or Cincinnati, OH.
The Ethicon 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 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.
Key Job Responsibilities:
Managing Post Market Surveillance processes focused on worldwide product performance and safety signal detection, including direct supervision of PMS Analyst(s)/Engineer(s). Direct responsibility for PMS process for business units within Ethicon (including all businesses impacted by the Ethicon and EES Quality Systems) for both Somerville and Cincinnati Campuses. Managing the execution of the Post Market Surveillance processes for product trending, trending review meetings, data management, PMS Plans, PMS Reports, Complaint Support, and Regulatory Support. Supporting the business planning and data deep dive processes to drive continuous improvement through data evaluation and presentation. Acting as the main point of contact for data needs and investigation support for the all worldwide support functions as it relates to product performance and complaint investigation. Driving collaboration and cross functional teaming between QSRC, LCM, R&D, Supply Chain, Medical Safety, Medical Affairs and Customer Quality organizations to develop and sustain processes that deliver customer focused solutions to product performance opportunities. Provides backup to Post Market Surveillance Director when required. Coordinates the trending and monitoring of all complaint and customer related data and feedback to include the calculation of control limits, support of CAPA Council and/or monthly complaint trending. Manages the creation and maintenance of Post Market Surveillance Plans, including for new products and existing products. Manages the creation and timely exection of Post Market Surveillance Reports and the complaince to the approved plans. Drive continuous improvement by establishing and maintaining processes that identify and correlate product trends with internal data streams to include manufacturing data, product complaint analysis findings, complaint data, or other relevant data sources. Provides field product information to Marketing and R&D as part of the strategic initiative of prouct enhancements/improvements. Identifies and drives continuous improvement in the PMS and data management processes as it relates to prouduct performance and complaint information. Supports projects relating to new product introductions to ensure Post Market Surveillance planning have been represented in the process including appropraite VOC, AFC and complaint category identification. Acts as a consultant and provides leadership on Post Market Surveillance projects. Supports the communication of follow-up letters/inquiries regarding MDR product complaints with the FDA and MDV product complaints with the Competent Authority, Authorized Representatives and Regulatory Franchise Managers as needed. Assists in providing analysis of trends and factors to the supply chain, LCM and Technical staff management for resolution. Coordinates the Corporate Document Retention Policy for PMS. SAFETY: Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies and procedures. Evaluate staff member’s safety performance and insure that safety is a part of each direct report’s OGSMs. Provide resources (time and money) necessary to maintain safety process. Ensure safety structure is in place in form of working committees and department coordinators. Provide a consistent point of contact between the Quality, LCM, Supply Chain and R&D organizations to include support of any product performance initiatives. Develop & implement appropriate metrics to track & monitor performance. Provide leadership to organization to ensure that all processes and systems comply with established specifications & regulations. Complete & deliver performance reviews of direct reports, and establish associate performance and potential ratings. Contract with direct reports to develop viable development plans & objectives; facilitate, coach & manage associates through the development process. Participate in and support up to possibly running CAPA/Monthly Trending meetings. Other responsibilities may be assigned & not all responsibilities listed may be assigned.
Qualifications
A minimum of a Bachelor's degree in Scientific, Technical, Engineering, Nursing or a related discipline is required. An advanced degree and/or MBA are a plus. A minimum of 2+ years of supervisory/people management experience is required. A minimum of 5+ years of progressive experience within a regulated industry (Medical Device, Pharmaceutical, or Consumer Good) is required. A demonstrated successful integration of Quality Systems elements and their management is preferred. Ability to lead cross-functional teams, sometimes requiring managing and leading without authority is also required. The ability to lead in a complex matrixed environment is required. A Green Belt, Black Belt Certification, PE Leadership training from J&J, CQE (Quality Engineer Certification), CRE (Reliability Engineer Certification), CQA (Quality Auditor Certification), or CQM (Certified Quality Manager) are preferred. Ability to translate large sets of quality data into actionable statistical analysis is also required. Knowledge and/or experience with ISO 14971 are preferred. This position will be based in either Somerville, NJ or Cincinnati, OH and requires up to 40% domestic travel, with the potential for international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
J2W:RAPS
J2W: ASQ_Phil
J2W: ASQ_Princeton
J2W: ASME
Primary Location:North America-United States-New Jersey-Somerville
Other Locations:North America-United States-Ohio-Cincinnati
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement