EPM Scientific has partnered with a medical device company that is looking to bring on a Quality Specialist - Post Market to their team on a contractual basis.
The Quality Specialist will have the following responsibilities:
- Investigating complaints to determine causes and complete medical device reporting in accordance with 21 CFR Part 803, European Vigilance Reporting
- Coordinating complaint investigations
- Support final closures by reviewing peer investigations
The Quality Specialist will have the following qualifications:
- Bachelors Degree
- 2+ years experience in QA Complaint Processing
- Proficiency in MS Office, Adobe Acrobat, etc
- Knowledge of Quality Systems (CAPA, SCARS, etc)
- Previous medical device experience including ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
This position is fully remote and starting on a 6 month contract
Benefits: health, vision, dental insurance, 401k
