Johnson & Johnson companies are equal opportunity employers.
GROUP LEAD, COMPLAINTS INVESTIGATION-00000JWI
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Group Lead, Complaints Group.
ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.
The following responsibilities will be included in the role, though not limited solely to this list: assist with Health Hazard Analysis and participate in Quality Review Board, as required. Responsible for oversight of Medical Safety Reviews and patient safety failure investigations. Write and submit baseline reports to the FDA in strict accordance with regulatory timelines. Ensure timely submission of MDR and vigilance reports. Identify emerging regulatory issues for management consideration. Collaborate with management to develop and maintain a global business process for regulatory compliance. Recommend and provide rationale for system enhancements of software applications.
Support efforts to develop a company-wide regulatory complaint handling system. Chair monthly complaint meeting with cross-functional representation. Present monthly update to CAPA Review Board. Manage correspondence in response to global regulatory agencies requests. Provide training to employees on annual basis at employee meeting and sales meeting. Responsible for taking appropriate steps to maintain confidentiality of patient information. Assist in FDA and Notified Body inspections. Assist with implementing productivity improvements. Assist in conducting literature searches.
Qualifications
BS / BSN Degree (science or engineering preferred) with 5 or more years of related experience and/or training in complaint/call center activities. Demonstrated analytical and oral/written communication skills, including ability to use independent judgment in decision-making, is required. The ability to lead a high performance team and drive performance results is required. Ability to identify and escalate product and organizational issues and trends is required. Knowledge of global adverse event reporting requirements. Experience making MDR reportability decisions. Ability to interface with Medical consultant(s) for MDR reportability decision is required.
The ability to interface with Medical consultant(s) for MDR reportability decisions is required. Experience with a complaints handling software is required. The ability to generate sound clinical rationale for non-reportable events based on clinical experience, medical opinion, professional literature and the AORN Standards (Association of Operating Room Nurses).
This position is located in Irvine, CA and requires 10% 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.
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
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
GROUP LEAD, COMPLAINTS INVESTIGATION-00000JWI
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Group Lead, Complaints Group.
ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.
The following responsibilities will be included in the role, though not limited solely to this list: assist with Health Hazard Analysis and participate in Quality Review Board, as required. Responsible for oversight of Medical Safety Reviews and patient safety failure investigations. Write and submit baseline reports to the FDA in strict accordance with regulatory timelines. Ensure timely submission of MDR and vigilance reports. Identify emerging regulatory issues for management consideration. Collaborate with management to develop and maintain a global business process for regulatory compliance. Recommend and provide rationale for system enhancements of software applications.
Support efforts to develop a company-wide regulatory complaint handling system. Chair monthly complaint meeting with cross-functional representation. Present monthly update to CAPA Review Board. Manage correspondence in response to global regulatory agencies requests. Provide training to employees on annual basis at employee meeting and sales meeting. Responsible for taking appropriate steps to maintain confidentiality of patient information. Assist in FDA and Notified Body inspections. Assist with implementing productivity improvements. Assist in conducting literature searches.
Qualifications
BS / BSN Degree (science or engineering preferred) with 5 or more years of related experience and/or training in complaint/call center activities. Demonstrated analytical and oral/written communication skills, including ability to use independent judgment in decision-making, is required. The ability to lead a high performance team and drive performance results is required. Ability to identify and escalate product and organizational issues and trends is required. Knowledge of global adverse event reporting requirements. Experience making MDR reportability decisions. Ability to interface with Medical consultant(s) for MDR reportability decision is required.
The ability to interface with Medical consultant(s) for MDR reportability decisions is required. Experience with a complaints handling software is required. The ability to generate sound clinical rationale for non-reportable events based on clinical experience, medical opinion, professional literature and the AORN Standards (Association of Operating Room Nurses).
This position is located in Irvine, CA and requires 10% 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.
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
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