What are the responsibilities and job description for the Quality Assurance Specialist position at The Fountain Group LLC?
The primary responsibility is managing the ETE IVDR/MDR product verification process for products within Roche's distributed products portfolio, including determining requirements and controls for those products and completing objective evidence of supplier evaluation and approval.
Duties:
- Manage SCARs (Supplier Corrective Action Requests) and successfully complete them, as well as address other supplier gaps in a timely manner by tracking robust corrective action plans.
- Complete onboarding activities for suppliers.
- Monitor supplier performance.
- Plan and follow up on supplier audits and ensure resulting supplier actions are sufficient to resolve quality issues and are completed in a timely fashion.
- Identify and escalate issues as they arise and provide adequate solutions.
Qualifications:
- Bachelor’s / Master’s degree in Life Science, Data Science, or a related subject or equivalent experience.
- 2 years of experience in Quality or a related function.
- Professional experience in a similar role within the medical device sector.
- Knowledge of deviation and resolution management.
- Expertise in quality systems, standards and regulations, specifically production and/or supplier development processes and standards such as ISO 13485 and ISO 27001.
Salary : $36