Neumodx Molecular, Inc.
Location
Ann Arbor, MI | United States
Job description
NeuMoDx Molecular Inc. (“NMDX”) designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. In addition to focusing design and development efforts on tests to detect Respiratory Infections, Sexually Transmitted and Infectious Diseases, NMDX has developed and commercialized a broad range of general purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDT’s) for use with the NMDX Molecular Systems to detect and amplify DNA and RNA targets.
Position: Complaint Intake Specialist – Ann Arbor, MI
Reports to: Field Service and Technical Support Manager
Location: Corporate office located in Ann Arbor, MI
Key Responsibilities:
Responsible for the product complaint intake and reporting process.
Receive complex medical information and ask probing questions to ensure the full picture of the complaint incidence is captured.
Evaluate event report to determine if it qualifies as a complaint.
Compile and organize complaint data and disseminate to Quality Affairs to aid in the analysis of customer complaint data to monitor and identify quality trends.
Work with Quality Engineers to ensure timely evaluation and completion of complaints.
Manage customer relationship and expectations during course of complaint investigation and resolution process.
Submit final complaint correspondence to the customer.
Obtain and submit complaint information to Regulatory Affairs based on FDA Medical Device Reporting and European Vigilance reporting requirements.
Maintain organized records following good documentation practices.
Adhere to applicable procedures contained within the NMDX Integrated Quality Management System (IQMS).
Perform all other duties as assigned by Field Service and Technical Support Mange
Knowledge, Skills, and Abilities necessary to perform essential functions
Strong interpersonal and communication skills.
Ability to work independently and meet deadlines.
Ability to organize and handle high pressure situations.>
Demonstrated leadership abilities and decision-making abilities.>
Minimum Requirements/Qualifications:
Associate degree (minimum) required in a clinical, scientific, or healthcare related field.
Minimum two years work experience or relevant industry experience in medical device field
One or more years work experience with medical device complaint handling desired
Clinical laboratory and/or regulatory experience desired
Must have good computer and software skills, including fluency with current Windows operating systems, Outlook, Excel, and Word programs.
Must have experience communicating effectively with a wide variety of people.
NMDX offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans.
For consideration, please submit resume along with salary requirements to [email protected] and mention the job description in the subject. No phone calls please. Only qualified candidates will be contacted.
Job tags
Salary
