Careers
Quality Systems Coordinator
Requisition Number: QSC-2055-002
Fujirebio Diagnostics, Inc. has an immediate opening for a Quality Systems Coordinator. The qualified individual will be responsible for:
Essential Job Functions:
- Maintaining the nonconformance and corrective action/preventive action (CAPA) programs
- Coordinating Quality Assurance (QA) complaint handling program
- Performing tracking and trending for the nonconformance, CAPA and complaint systems
- Reviewing quality investigations associated with nonconformances, CAPA and complaints for compliance to quality procedures
- Conducting quality investigations and preparing investigation reports as required
- Providing reports on document error rates and other metric indicators of quality performance
- Providing back up to QA management for identified functions
- Managing QA improvement and training projects
- Providing support for the management review of the quality system
- Assisting in assessing compliance requirements for products and processes in development
- Assuring overall compliance with internal specifications, customer/partner specifications and FDA regulations
- Assisting with compliance and regulatory affairs projects and activities as needed
Qualified candidate will have B.S. degree in Science (life science or medical technology preferred); knowledge of cGMP’s, QA, QC and manufacturing/quality processes; 5 years experience in an FDA regulated industry; thorough working knowledge of FDA regulations, ISO 13485 standards and compliance/quality assurance requirements; ASQ certification desired; strong management and leadership skills; detail oriented; excellent organization skills and ability to multi task; excellent communication skills and ability to work with all levels of staff; strong PC skills.
FDI is one of the Top 100 Companies To Work For In Pennsylvania. We offer a competitive compensation and benefits package and a convenient Malvern location.
To apply, email resume to HR@FDI.com.
EOE M/F/D/V
We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.