Complaints Analyst II (1 of 2)

Johnson & Johnson Family of Companies - Irvine, CA (30+ days ago)4.3


Johnson & Johnson's Family of Companies - Biosense Webster, is recruiting for a Complaints Analyst II to be located in Irvine, CA to support our Advanced Sterilization Products (ASP) business.

Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products(ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.

You, 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 individual applies standard practices and techniques in specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.

You, the Complaints Analyst II will:
Be responsible for complaint management (Entry, Closure, Follow ups, etc)
Write customer response letters, as required
Be responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.
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.
Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services.
Establish reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up.
Possess a thorough understanding of the complaint database.
Develop, establish, prepare and distribute dashboards and reports to assure complaints are processed in a timely manner
Understands basic principles, theories, concepts and techniques related to customer complaints.
Escalate critical issues for proper disposition as necessary.
Investigate and develop solutions to procedure and process related issues.
May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures.
Support and/or lead CAPA investigations
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.
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.
May be responsible for training other staff members.
Supports Product Analysis if required
Be responsible for communicating business related issues or opportunities to next management level
Be responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Be responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Perform other duties assigned as needed

Qualifications
Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products(ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.

A Bachelor’s degree in computer science, engineering, physical, biological, natural sciences or other related field is required.
A minimum of 2-4 years of quality, manufacturing, or regulatory experience in a medical device or other regulated industry is required.
Critical thinking and investigation skills are required.
The ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
Must be able to effectively prioritize and manage multiple activities and responsibilities.
The ability to understand and follow complex written procedures is required.
Knowledge of general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices is required.
The ability to function in a team environment and deliver on team objectives is required.
The ability to influence and drive change is preferred.
Project management and/or process mapping experience is preferred.
Strong written and verbal communication skills are required.
Developed presentation skills are preferred.
Professional demeanor on the phone and in email is required.
Familiarity with computers and Windows-based PC applications is required.
Ability to learn and manipulate complex computer system applications is required.
Prior medical device complaint handling experience, or knowledge of medical device regulations is preferred.
American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred.
This position will be located in Irvine, CA and may require up to 10% domestic and/or internationally travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-California-Irvine
Organization
Biosense Webster Inc. (6010)
Job Function
Quality (Eng)
Requisition ID
0091180427