J&J Family of Companies COMPLAINTS ANALYST II in Juarez, Mexico

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Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias. We help patients around the world regain their health, their energy and their lives. Guided by the needs of electrophysiologists and cardiologists, Biosense Webster, Inc. has pioneered innovative technological advancements for more than 30 years. Join us as we continue to look for new and better ways to help physicians heal more hearts. Because that is what we do -- we put lives back in rhythm.

Searching the best talent for: COMPLAINTS ANALYST II

Description:

Under minimum supervision, 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Activities related Complaint Handling:

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

• Write customer response letters, as required

• Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.

• 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.

• Write customer response letters, as required.

• Guarantees all required regulatory reports are completed and reported according to regulatory requirements.

• 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, and analyze trend reports for complaints on a weekly and monthly basis, as required.

• 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.

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

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

• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

• 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.

• Escalate critical issues Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate. Assist in complaint analysis. Assist Regulatory Affairs in developing submissions for new devices for proper disposition as necessary.

• May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical and regulatory expertise with others.

• Work is expected to result in the development of new or improved techniques or procedures.

• May be responsible for training other staff members

• Develop and establish effective quality control and associated risk management plans as needed.

• Responsible for submitting MDRs to FDA and work with worldwide groups to assure regulatory compliance in countries outside United States.

• Responsible for communicating business related issues or opportunities to next management level

• 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

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

Activities related Trending and Escalation:

• Escalate critical issues for proper disposition as necessary.

Other:

Investigate and develop solutions to procedure and process related issues.

• 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.

• 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 ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

• Performs other duties assigned as needed

RESPONSABILIDADES DE SUPERVISION INGENIERO ASOCIADO, NIVEL 1, SENIOR Y STAFF.

• Responsable de llevar a cabo revisiones de diseños y evaluaciones de pre-validaciones para asegurar el inicio de nuevos procesos, en lo referente al ambiente y seguridad.

• Responsable de la comunicación de las cuestiones y oportunidades relacionados con el negocio al siguiente nivel de gestión

• Para los puestos con responsabilidades de supervisión, asegúrese de que los subordinados siguen todos los alineamientos de la compañía relacionados con la salud, seguridad y prácticas ambientales y que todos los recursos necesarios para ello están disponibles y en buenas condiciones

• Responsable de cumplir con los procedimientos y políticas de la compañía y con todas las Leyes y Regulaciones Locales, Estatales y Federales,

• Cumplir con los procedimientos de Calidad, Leyes y Regulaciones a los mercados aplicables

• Realiza otras tareas asignadas, según sea necesario

Reporting to: COMPLAINTS HANDLING UNIT MANAGER

Qualifications

EDUCATION/TRAINING and/or EXPERIENCE:

• BS in computer science, engineering, physical, biological, or natural sciences or 2 years of related medical device or other regulated industry experience in quality, manufacturing, or regulatory is required.

• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable

.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

• Must possess the basic understanding of engineering fundamentals.

• Good written and oral English communication skills.

• Must be computer literate.

ADDITIONAL POSITION REQUIREMENTS: Include whether or not position will be required to work in clean room, near or with heavy machinery, ability to lift heavy objects, ability to wear protective gear in lab, etc.

Global Leadership Profile Competencies

Collaboration and Teaming puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset

Results and Performance Driven assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent

Prudent Risk-taking inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses

Sense of Urgency proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed.

Organization

BWI

Aplicar hasta: diciembre 2,2016

Primary Location

Mexico-Chihuahua-Juarez

Organization

Cordis de Mexico S.A. de C.V. (8286)

Job Function

Quality (Eng)