Johnson & Johnson companies are equal opportunity employers.
COMPLAINTS SPECIALIST II-8259140410
Description
Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Complaints Analyst II, to be located in Irwindale, California
Hi-Tech meets Medical Devices at Biosense Webster! If you want to work with brilliant people in a fast paced environment, help make a huge difference in patient's lives and want to be responsible for providing the most innovative technology in the field of cardiac electrophysiology, then Biosense Webster is the place for you! Our vision and mission are clear - be #1 in rhythm solutions globally and cure AF (Atrial Fibrillation), the most common heart arrhythmia. Our products are used by prominent physicians around the world and help improve thousands of patient's lives. Simply put, we are a highly innovative entrepreneurial company with a truly global and diverse culture, backed with the support structure of the Johnson & Johnson Corporation - quite a winning combination! Our commitment to quality and our Credo have helped us achieve significant milestones as a company.
Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren’t stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Complaints Analyst II will be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards. This individual will review documentation from incoming calls, faxes, and emails from all areas of the world. This individual will also obtain adequate information to ensure proper documentation, investigation, and closure of each complaint, in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.
The Complaints Analyst II will ensure all required information is obtained and properly documented to make sound regulatory reporting decisions. In addition, this individual will evaluate all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure. This individual will write customer response letters, as required. The Complaints Analyst II will guarantee all required regulatory reports are completed and reported according to regulatory requirements. This individual will establish reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up. This individual will develop a thorough understanding of the complaint database. Additionally, the Complaint Analyst I will develop, prepare, and analyze trend reports for complaints on a weekly and monthly basis, as required.
The Complaint Analyst II will set up monthly complaint meetings and communicate with worldwide complaint groups, as well as other internal departments including Marketing, R&D, Customer Service and Technical Services. This individual will have a fundamental understanding of basic principles, theories, concepts and techniques related to customer complaints. This individual will investigate and develop solutions to procedure and process related issues. Also, this individual will be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Qualifications
A minimum of a High School Diploma or equivalent combined with five (5) + years’ experience in a highly regulated industry (e.g., FDA, ISO, and/or regulated environment) is required. A Bachelor's degree in an Engineering, Life Sciences, Scientific, Nursing, or related discipline combined with three (3) + years’ experience in a highly regulated industry (e.g., FDA, ISO, and/or regulated environment) is preferred. Knowledge of GP (Good Practices) requirements from manual to electronic processes and HIPPA (Healthcare Information Patient Privacy Act) is preferred. Proficiency with Microsoft Office, specifically with Microsoft Excel is required. Experience with Microsoft Access is preferred. Complaint management/input system experience such as Seibel, Oracle, or a similar system is a plus. Knowledge of Medical Device, MDR (Medical Device Reporting), MDV (Medical Device Vigilance), and/or worldwide reporting is preferred. Familiarity with tracking and trending processes is considered an asset. Outstanding written and verbal skills, as well as great interpersonal skills are required. An individual with strong Leadership Skills, experience with Project Management, and who is investigative and analytical is strongly preferred. This position will require 10% travel and will be based in Irwindale, CA.
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
Primary Location:North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)
Job Function: Quality Systems
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
COMPLAINTS SPECIALIST II-8259140410
Description
Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Complaints Analyst II, to be located in Irwindale, California
Hi-Tech meets Medical Devices at Biosense Webster! If you want to work with brilliant people in a fast paced environment, help make a huge difference in patient's lives and want to be responsible for providing the most innovative technology in the field of cardiac electrophysiology, then Biosense Webster is the place for you! Our vision and mission are clear - be #1 in rhythm solutions globally and cure AF (Atrial Fibrillation), the most common heart arrhythmia. Our products are used by prominent physicians around the world and help improve thousands of patient's lives. Simply put, we are a highly innovative entrepreneurial company with a truly global and diverse culture, backed with the support structure of the Johnson & Johnson Corporation - quite a winning combination! Our commitment to quality and our Credo have helped us achieve significant milestones as a company.
Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren’t stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Complaints Analyst II will be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards. This individual will review documentation from incoming calls, faxes, and emails from all areas of the world. This individual will also obtain adequate information to ensure proper documentation, investigation, and closure of each complaint, in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.
The Complaints Analyst II will ensure all required information is obtained and properly documented to make sound regulatory reporting decisions. In addition, this individual will evaluate all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure. This individual will write customer response letters, as required. The Complaints Analyst II will guarantee all required regulatory reports are completed and reported according to regulatory requirements. This individual will establish reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up. This individual will develop a thorough understanding of the complaint database. Additionally, the Complaint Analyst I will develop, prepare, and analyze trend reports for complaints on a weekly and monthly basis, as required.
The Complaint Analyst II will set up monthly complaint meetings and communicate with worldwide complaint groups, as well as other internal departments including Marketing, R&D, Customer Service and Technical Services. This individual will have a fundamental understanding of basic principles, theories, concepts and techniques related to customer complaints. This individual will investigate and develop solutions to procedure and process related issues. Also, this individual will be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Qualifications
A minimum of a High School Diploma or equivalent combined with five (5) + years’ experience in a highly regulated industry (e.g., FDA, ISO, and/or regulated environment) is required. A Bachelor's degree in an Engineering, Life Sciences, Scientific, Nursing, or related discipline combined with three (3) + years’ experience in a highly regulated industry (e.g., FDA, ISO, and/or regulated environment) is preferred. Knowledge of GP (Good Practices) requirements from manual to electronic processes and HIPPA (Healthcare Information Patient Privacy Act) is preferred. Proficiency with Microsoft Office, specifically with Microsoft Excel is required. Experience with Microsoft Access is preferred. Complaint management/input system experience such as Seibel, Oracle, or a similar system is a plus. Knowledge of Medical Device, MDR (Medical Device Reporting), MDV (Medical Device Vigilance), and/or worldwide reporting is preferred. Familiarity with tracking and trending processes is considered an asset. Outstanding written and verbal skills, as well as great interpersonal skills are required. An individual with strong Leadership Skills, experience with Project Management, and who is investigative and analytical is strongly preferred. This position will require 10% travel and will be based in Irwindale, CA.
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
Primary Location:North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)
Job Function: Quality Systems
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