Quality Systems Coordinator-Documentation

Where

Southington, CT

What you'll be doing

Responsible for the review and approval of the device history record. Responsible for the post sterile product release, which include, when required, prepare the sample for each sterility run order. Perform the review of the sterilization record to ensure compliance to specification. Review the post sterile test result to ensure that the product meet all specification requirement. Communicate quality and compliance issue to different organizational level. Interact with internal, external and corporate auditor. Support planning/operation with review of the schedule of product release. Coordinate/monitor sterile product return due to discrepancy, product correction, field recall. Monitor post sterile product non conformance and hold. Assist microbiology with activity required for sterilization cycle validation. Ensure compliance to company policy and business practice, FDA QSR regulation, GMP and ISO 13485 compliance. Escalate all non conformance and compliance discrepancy to the QS manager. Make decision based on the review of the record. Perform all necessary Oracle system transaction related to the final release of the product from the factory.

What your background should be

Five to seven years of experience in a FDA regulated company or similar environment with quality system experience in GMP and ISO quality system standards. Good leadership, collaboration and stakeholder management skills. Excellent verbal communications skills. Good decision making and problem solving skills. Detailed oriented. Ability to handle and work under stressful situations. Ability to interact with sterilization facilities and resolve issues. Ability to handle multiple tasks in a fast paced environment. Ability to prioritize work schedules while maintaining flexibility. Ability to lift and/or push up to 35 lbs.

Required Schooling / Training

Associate degree required, bachelor degree preferred.

Who is the client company

This is a leading global provider of medical devices for the hospital, emergency, home and specialist environments.

If you are interested in this position, send your resume to apply@kochdavis.com