At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Ciudad Juarez, Chihuahua, Mexico

Job Description:

Coordinates and assists with the documenting business critical issues in Customer/Commercial Quality. Applies functional knowledge of Customer/Commercial Quality and identifies regulatory standards and policies that may impact organizational objectives. Assists with routine collection and dissemination of customer feedback, metrics, and key performance indicators to ensure continuous improvement of the quality management system. Carries out processes to ensure internal and key external business partner organization's alignment and fulfillment of quality and regulatory requirements with overall quality priorities, under direct supervision. Follows formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems. Carries out customer handling complaint process, and establishes and maintains Quality System Elements. Analyzes basic research and data related to regulatory changes, external trends, and strategy. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. This job does not require any experience. This job is overtime eligible.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

We are searching for the best talent for COMPLAINT ANALYST I to be in Ciudad Juarez, Mexico.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate

Johnson & Johnson, procedures and guidelines, this position:

• Responsible for complaint management (Entry, Follow ups, Product Analysis, Closure, etc.)

• Possess a thorough understanding of the complaint database.

• Understands basic principles, theories, concepts, and techniques related to customer

complaints.

• Establish reports for the prompt review of new complaints, regulatory reporting decisions, and

follow-up.

• Develop, establish, prepare, and distribute dashboards and reports to assure complaints are

processed in a timely manner.

• Responsible for coding the event and ensuring that all the required information for a complaint file

is obtained and properly documented to make a final regulatory reporting decision.

• Evaluates 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.

• Responsible for tracking, receiving, and shipping products as needed.

• Execute the complaints analysis and failure investigations daily and document the analysis results

and relevant information to the Med Watch reports in the assigned product families.

• Approve the complaints in the assigned product families.

• 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.

• Write customer response letters, as required.

• Escalate critical issues for proper disposition as necessary, and in accordance with the applicable escalation procedures.

• Other Activities:

• Provide support in the training of the complaints process for new analysts or technicians if the analyst has been identified as a subject-matter expert.

• Investigate and develop solutions related to procedures and process issues.

• May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.

• Participate in Quality improvement processes and projects.

• Provide support in product transfer and new product development as needed.

• 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.

• Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that 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, if applicable o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed
  
  

Requirements:

Education:

• A Bachelor’s degree or equivalent is required

Experience and Skills:

Required:

• Close to completion of college career or recently finished or equivalent experience, preferably in

computer science, engineering, physical, biological, or natural sciences.

• Preferably with 0 to 2 to years of quality, manufacturing, or regulatory experience in medical

devices or other regulated industry.

• Preferably American Society for Quality (ASQ) certification, Six Sigma experience, and/or

knowledge of Process Excellence tools.

• Critical thinking and investigation skills are required.

• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.

• Employee must be able to effectively prioritize and manage multiple activities and responsibilities.

• Ability to understand and follow complex written procedures is required. Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.

• Ability to function in a team environment and deliver on team objectives is required. Ability to influence and drive change. Preferably, project management and/or process mapping experience.

• Communication Skills: Strong written and verbal communication skills. Must be highly proficient in reading, writing, and speaking the English language. Preferably, presentation skills.

• Professional demeanor on the phone and in email is required. Technical writing is a routine part of this position. Strong attention to detail is required.

• Required Computer Skills: Familiarity with computers and Windows-based PC applications. Ability to learn and manipulate complex computer system applications is required. Experience with word processor software (e.g., Microsoft Word) and internet browsers (e.g., Internet Explorer) is required. Prefer experience with Enterprise Complaint Management System (ECM).

• Preferably, prior medical device complaint handling experience, or knowledge of medical device regulations.