AnnArborRecruiter Since 2001
the smart solution for Ann Arbor jobs

Complaints Specialist (contract)

Company: NeuMoDx/Qiagen
Location: Ann Arbor
Posted on: January 15, 2022

Job Description:

The Complaints and Vigilance (Contract) will be responsible for monitoring and assessing complaints for reportability, and preparing necessary documentation for regulatory reporting as required.--He/she will also monitor and help organize field correction activities, including regulatory requests and customer responses.

  • Reviews and assesses complaints for reportability to regulatory authorities (FDA and ex-US).
  • Monitors complaint trends and recommends corrective actions as appropriate.
  • Plays a key role in controlling and monitoring distributed product, and recalled product through closure of field corrective actions.
  • Other responsibilities as assigned and relevant to Associate's competencies or training.
    • BA/BS/MS, in scientific or engineering discipline, prefer Life Science, IVD or Medical Device discipline.
    • A minimum of 3 years' experience in an FDA regulated industry preferred.
    • Working knowledge of complaint investigations and medical device reporting requirements.
    • Working knowledge of 21CFR820 and ISO 13485:2019.
    • Proven experience in IVD industry is a strong plus.
    • Demonstrated experience working with cross-functional groups (R&D, Operations, Clin/Reg, etc.) requiring strong interpersonal skills, excellent communication skills, and the ability to work well under pressure.
    • Proficiency with Microsoft Word, Excel and PowerPoint for data analysis and report generation is a must.

Keywords: NeuMoDx/Qiagen, Ann Arbor , Complaints Specialist (contract), Other , Ann Arbor, Michigan

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Michigan jobs by following @recnetMI on Twitter!

Ann Arbor RSS job feeds