Quality Systems Manager – Snelling – Huntsville, AL, USA
Our client is seeking a Quality Systems Manger to develop, implement and maintain a quality system in accordance with FDA Quality System Regulations, GMP guidelines and ISO 13485 requirements. Additionally, the Quality Systems Manager will guide multiple products through a FDA 510(K) process.
- Manage Quality Control team, laboratory and analytical quality control testing. Maintain a controlled environment through an environment monitoring plan, personnel controls and exceptional laboratory material.
- Develop and lead a broad set of FDA Quality Compliance, Release and Systems activities for the successful production and release of in-vitro diagnostic products.
- Manage Non Conformance Reports and all Corrective and Preventative Actions.
- Work with Regulatory Consultant to prepare 510K submission.
- Oversee implementation of Quality System and the development of new SOP’s, FORMs, Test Procedures and Work Procedures.
- Manage changing conditions, processes and approaches; lead organizations through change effectively.
- Strong understanding of Supplier Quality, Cold Chain Management, Logistics and Distribution, Design Control, Risk Analysis, and Statistical Process Control.
Education and Required Skills Experience:
- Bachelors of Science in biochemistry, molecular biology, microbiology, chemistry or genetics
- 2+ years medical device product development
- 2+ years working in FDA-regulated Quality Environment
- 2+ years writing protocols, SOPs, etc.
- 2+ years managing a team in a clinical environment
- Working knowledge of ISO 13485 and FDA 21 CFR 820 Quality System Regulation
- Experience in molecular biology or molecular diagnostics a plus
- QC method design, optimization and validation experience require
Salary will be based on experience!
All qualified and interested candidates please send your current resume and salary requirements to: firstname.lastname@example.org