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Job ID 203825BR
Posting Title: Medical Device Complaint Handling Specialist
Business Unit: QUALITY ASSURANCE AL
Work Location: Fort Worth, TX
Company/Legal Entity: Alcon Laboratories, Inc.
Functional Area: Quality
Therapeutic/Disease Area: Ophthalmic/Ophthalmology
Job Type: Full Time
Employment Type: Regular
•Responsible for day-to-day case management of quality technical and adverse event com-plaint records, including intake, follow up, triage and system entry, involving Alcon device products.
•Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives.
•Receive initial complaint from any source (ECPs, patients, internal Alcon personnel) and assure all information/data is accurately captured at point of contact
•Maintain an understanding of information/data required to be collected for technical and AE complaints to assure compliance with regulations and directives.
•Manage technical and adverse event complaint records for assigned area(s) using designated safety system(s)
•Review potential complaint data received via safety system(s) and other methods, as required
•Is cognizant of, and works efficiently within applicable time zones
•Performs intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per requirements and directives.
•Performs data entry for affiliates without access to safety database(s).
•Triage call from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit.
•Reviews data entry and follow-up activities for completeness and timeliness
•Closes files according to established guidelines to meet required timelines
•Maintains a working knowledge of company policies and procedures, departmental processes, and associated work instructions
•Evolving local and international regulations, guidelines and applicable directives
•Alcon products for assigned therapeutic area(s) and corresponding documentation (Product Inserts, DFUs, Manuals, Promotional Materials)
•Eye anatomy, common diseases, and ophthalmic procedures
•Eye terminology and abbreviations
•Safety databases(s) and reporting tools
•Informs management of potential safety issues, emerging trends and/or concerns
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to firstname.lastname@example.org and let us know the nature of your request and your contact information
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
•Bachelor's degree or equivalent years of directly related experience. RN or BSN highly desired.
•5 years directly related experience
CLICK HERE the link to apply.
AMBULATORY CARE NURSE II - Private Diagnostic Clinics - PDC Ophthalmology
Requisition # 401176238 - Direct Apply
General Description of the Job Class
Independently plan and provide professional nursing care for patients in ambulatory clinic settings in accordance with the medical and nursing plans of care and established policies and procedures.
Provide nursing services to patients and families in accordance with the scope of the RN as defined by the North Carolina Board of Nursing.
Duties and Responsibilities of this Level
- Plan, provide and document professional nursing care in ambulatory settings, utilizing the nursing process, in accordance with physician orders and established policies and procedures, under the supervision of the nurse manager, charge nurse or practice manager.
- Collect and analyze patient data, make recommendations for nursing care plans, evaluate nursing care provided, document and communicate appropriately nursing actions taken and patient responses.
- Delegate tasks and supervise the activities of other licensed and unlicensed care providers.
- Assist other nursing personnel in the delivery of patient care and serve as a team leader.
- Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources.
- Participate in own professional development by maintaining required competencies, identifying learning needs and seeking appropriate assistance or educational offerings.
- Support the development of other staff and formal learners.
- Participate in the identification of clinical, operational and safety related performance improvement opportunities.
- Participate in clinic or entity level performance improvement activities.
- Perform other related duties incidental to the work described herein.
Knowledge, Skills, and Abilities:
- Knowledge of scope of the registered nurse, licensed practical nurse and all unlicensed assistive personnel
- Knowledge of and appropriate application of the nursing process
- Knowledge of professional theory, practice and procedures
- Ability to assess nursing needs of acute and chronically ill patients and their families
- Ability to independently seek out resources and work collaboratively
- Ability to establish and maintain effective working relationships
- Ability to communicate clearly with patients, families, visitors, healthcare team, physicians, administrators, leadership and others
- Ability to teach patients and families in accordance with the nursing plan of care
- Ability to use sensory and cognitive functions to process and prioritize information, treatment, and follow-up
- Ability to use fine motor skills
- Competent in BLS and/or other specialized life support requirements designated by work area or organization
- Ability to record activities, document assessments, plan of care, interventions, evaluation and re-evaluation of patient status
- Ability to use the computer and learn new software programs
- Ability to document and communicate pertinent information using computer and/or paper documentation tools
- Ability to navigate the entity to provide clinical care for patients
- Ability to withstand prolonged standing and walking with the ability to move or lift at least fifty pounds
- Ability to remain focused and organized
- Working knowledge of procedures and techniques involved in administering routine and special treatments to ambulatory patients
- Working knowledge of infection control procedures and safety precautions
- Working knowledge and completion of appropriate TJC and other regulatory requirements
- Administrative duties may include but not limited to the following:
- Answer telephones
- Greet patients
- Fill out insurance forms
- Handle correspondence
- Schedule appointments
- Arrange for hospital admissions
- Arrange for laboratory services
- Perform other administrative duties as directed.
- Clinic Duties may include but not limited to the following:
- Assist medical and nursing staff in a variety of tasks including:
- Must be able to work under time pressures in a busy clinic environment.
- Must be present on site for 8-9 hour shifts during standard clinic hours.
- Must participate in group activities requiring interpersonal skills and cooperation.
- Must work as late person once per week.
- Must be able to react quickly and immediately respond to emergencies.
- Must be able to handle multiple assignments, conflicting demands or priorities.
- Must maintain attention to detail over extended period of time, and be continually aware of variations in changing situations.
- Must be able to move throughout the clinic environment throughout duration of shift.
- Must be able to lift 50 lbs.
- Must be about to carry 30 lbs.
- Must be able to reach for objects by extending arms.
- Must be able to push/pull 200 lbs.
- Taking medical histories and recording vital signs
- Explaining treatment procedures to patients
- Preparing patients for examinations and procedures
- Assisting the physician during the examination and procedures
- Collect and prepare laboratory specimens
- Dispose of contaminated supplies
- Promote patient/family understanding of the educational content and his/her involvement in the plan of care, and document in patient record.
- Prepare and administer medications as directed by a physician
- Authorize drug refills as directed and by protocols
- Telephone prescriptions to a pharmacy.
- Prepare patients for tests and procedures.
- Take electrocardiograms
- Perform other clinical functions as delegated and supervised by the physician.
- Must have language skills appropriate to effectively and professionally communicate with patients via telephone, EHR Inbasket messaging, as well as face to face in person.
- Must be able to handle multiple assignments, conflicting demands or priorities
- Must be able to tolerate long periods of walking and/or long periods of sitting
- The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position.
- Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender identity, national origin, race, religion, sexual orientation, or veteran status.*******************************************************Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Required Qualifications at this Level
Education: Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program.
All registered nurses without a Bachelor's degree in Nursing (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date.
Twelve months of appropriate clinical experience is required. At a manager's discretion, employees with 6 months of experience who are exceptional performers may be eligible for this level.
Degrees, Licensure, and/or Certification:
Must have current or compact RN licensure in the state of North Carolina.