SUMMARY: Responsible for complaint data entry, coordinate investigation initiation, coordinate review and follow-up, closure, and trend analysis on complaint data. Makes medical device reporting decisions and reports Adverse Events to both US and International agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.
On a daily basis, reviews and processes assigned complaint records related to product quality and patient safety.
Reviews complaints for possible Adverse Events/MDRs and makes regulatory reporting decisions. Prepares and submits Adverse Events/MDRs to regualtory agencies in a timely manner to meet regulatory deadlines.
Conducts and coordinates complaint investigations and the input of information documenting same into the complaint tracking system.
Review technical service calls to determine appropriate classification.
Work with Factory Service/Engineering to coordinate failure analysis on customer returned product.
Ensures complaint files are investigated, complete and closed in a timely manner.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Assists with gathering, compiling and analyzing complaint trend data. Participates in complaint review board meetings.
Perform other quality assurance and quality control functions as necessary, with appropriate training.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
Bachelor's degree (B.S.) from a four-year college or university in the sciences or related field, or equivalent combination of education and experience
Minimum of 6 years’ experience in the medical device industry (or related industry) with complaint handling experience or 6 years of Clinical experience in the medical device industry.
Current knowledge of FDA and international quality system requirements are a must
Specific experience following Device Design Controls and Risk Management Processes preferred
Experience with Electronic Medical Equipment preferred
Technical writing is a plus
Other Skills and Abilities:
Generating quality metrics
The Food and Drug Administration’s Quality System Regulations (FDA’s QSR)
International standards such as ISO 13485, ISO 14971
Medical Devices Directive (MDD)
Canadian Medical Device Regulations (CMDR)
Product Performance Standards (IEC 60601-1 and collaterals)
Project planning a plus
Microsoft Excel and Word
Must possess strong oral and written communication and interpersonal skills
Must possess strong organizational skills
Must be adept at handling multiple assignments, multi-tasking, prioritizing and meeting deadlines.
Must be able to maintain regular attendance.
Ability to read, analyze and interpret general business periodicals, professional journals and technical procedures. Ability to write reports and business correspondence. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables, in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to resolve complex systems problems and identify solutions to obstacles encountered while resolving problems.
Certificates, Licenses, Registrations:
Certification by ASQ or (RAC) is a plus.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is regularly required to work at a keyboard and computer. Specific vision abilities required by this job include close vision and the ability to adjust focus. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status
Additional Salary Information: Benefits:
Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, an employee stock purchase plan, 9 paid holidays, generous paid time off plan (4 weeks to start) and tuition reimbursement up to $5,000 annually
Natus is a leading provider of healthcare products and services used for the screening, detection, treatment, monitoring and tracking of common medical ailments in neurological dysfunction, epilepsy, sleep disorders, newborn care, hearing impairment and balance and mobility disorders.