Staff Complaints Analyst

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We are searching for the best talent for STAFF COMPLAINTS ANALYST to be in Juárez (SALVARCAR) Purpose: On a supervisor role, the Staff Complaints Analyst 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 (including testing devices), 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 will be responsible for : 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 the overall Complaint Management process (Entry, Follow up, Product Investigation, Closure, etc.)
• Develop and coordinate workload of Complaints Analysts • Responsible for CSS and J&J Complaints Metrics • Possess a thorough understanding of the complaint database.
• Plan, develops, coordinate and/or support Departmental projects from different levels of complexity • Responsible of complaint coding and ensuring that all the information required for the complaint file is obtained and properly documented to make sound regulatory reporting decisions.
• 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, device investigations and follow-up.
• Guarantees all complaints are processed/investigated on a timely manner • Develop, establish, prepare and distribute dashboards and reports to assure complaints are processed in a timely manner.
• Deeply understands principles, theories, concepts and techniques related to customer complaints.
•Investigate and develop solutions to procedures and process related issues to next management level.
Activities related Trending and Escalation: • Escalate critical issues for proper disposition as necessary according to the applicable procedures.
People Management and Talent Development: • In a supervisory capacity, develops, mentors, plans and coordinates workload for Complaints Analysts in the Juarez Facility.
• In a supervisory capacity, plans, develops, coordinates, and directs projects with varying levels of complexity.
• In a supervisory capacity, plans, develops, coordinates, mentors, and directs technicians and junior level analysts.
• Responsible for conducting Performance Reviews and set Goals & Objectives for Complaints Analysts in the Juarez Facility.
• 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 Other Assignments: • Provide training to new associate Analyst or technician to complaint process as needed.
• Investigate and develop solutions to procedure and process related issues.
• Participate in process/ quality improvements projects.
• Provides support in product transfers and new products development, as required.
• Responsible for conducting Performance Reviews and set Goals & Objectives for Complaints Analysts • 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 • 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• BS completed.
Preferably in computer science, engineering, physical, biological, or natural sciences required, along with a minimum of 8 years of quality, manufacturing, or regulatory experience in a medical device or other regulated industry is required, or equivalent combination of medical device or other regulated industry is required, or equivalent combination of experience and education (Master Degree plus 2 years of experience).
Master's degree is preferred.
American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
• 3 years of previous supervisory experience • Supervisory and leadership skills • Regulatory compliance knowledge • Excellent interpersonal skills • Advanced Quality Assurance and Quality systems knowledge • Problem Solving • Statistical skills • Must possess the basic understanding of engineering fundamentals.
• Good written and oral English communication skills.
• 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 is preferred.
Prefer project management and/or process mapping experience.
• Communication Skills: Strong written and verbal communication skills are required.
Must be highly proficient in reading, writing, and speaking the English language.
Prefer developed presentation skills.
• Professional demeanor on the phone and in email 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 (ECM) System