at Spectraforce Technologies Inc. in WaukeganNorth Chicago, Illinois, United States
Job Description
Job Title: Product Surveillance Tech
Duration: 6 Months ( Posibility of extension)
Location: North Chicago, IL (60064)
What are the top 3-5 skills, experience or education required for this position:
1. Bachelor's degree and 1-2 year in customer service or clinical setting or equivalent combination of education and experience.
2. Familiarity with Regulation pertaining to devices/510K (i.e. FDA, MHRA, etc.)
3. Flexibility in managing multiple tasks and expectations.
JOB SUMMARY:
Under general direction, the Post market QA PMQA Analyst I will investigate and maintain complaint files, in compliance with regulations established by the FDA and international regulatory bodies and submit safety reports to the FDA and international Competent Authorities.
In addition will process claims for financial reimbursement and replacement products in accordance with client/ Allergan's reimbursement policy. Act as a key resource within the department by mentoring Representatives, monitoring complaints and call queues, and providing ongoing coaching and training. The Post market QA PMQA Analyst is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Provides technical and administrative support to internal and external customers.
"The candidate must conduct their work activities in compliance with all client/Allergan internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971. client/Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives."
KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:
1. Initiate, investigate, and maintain complaint files following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information obtained and make follow up calls to reporters.
* Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files. Code complaint information according to Post Market Spreadsheet Report (PSR), Retrieval Program.
* Assess incoming documentation, including clinical forms and medical information, for complaint data and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Evaluate internal and external lab analysis. Coordinate with inter- and intra-departmental customers to ensure complaints and inquiries across product lines are handled appropriately.
* Initiate Further Investigation and any additional follow-up and communication pertinent to the MDR as needed. Track files sent to Quality Assurance for Further Investigation and complete necessary documentation. Evaluate Further Investigation results, summarize findings, and determine and document the conclusion(s).
* Assist Supervisors and Manager in monitoring complaint and claims workflow to ensure compliance and customer service.
* Assist in resolving issues by responding to inquiries and answering technical questions regarding Allergan/ client product line.
Education and Experience:
Bachelor's degree with one to two years previous experience in customer service or clinical setting or equivalent combination of education and experience.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)?
* Customer service experience
* Familiarity with Regulation pertaining to devices/510K (i.e. FDA, MHRA, etc.)
* Flexibility in managing multiple tasks and expectations.
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
