Job Details

Position Summary

Responsible for supporting and maintaining AtaCor Medical's quality system processes to ensure their timeliness, effectiveness and compliance.

Essential Functions:

Document Control Coordinator:

· Process document change orders in QCBD

Records Management:

· Coordinate the receipt and filing of DHR, DMR, quality system, clinical and manufacturing records

Complaint Coordinator:

· Assess product experience reports per defined process to determine if event qualifies as a complaint

· Facilitate complaint process, from assignment of complaint to closure, per procedural requirements and AtaCor objectives, with oversight from manager

· Coordinate management of returned devices, including shipment for decontamination and/or complaint investigation activities

Inventory Management:

· Perform inspection of incoming finished devices

· Maintain product inventory logs

· Prepare product for shipment

Equipment Coordinator:

· Facilitate AtaCor's equipment controls program, which requires other parties to evaluate, qualify, calibrate and maintain production, engineering and clinical equipment.

· Coordinates equipment calibration and maintenance activities and records.

Supplier Coordinator:

· Performs activities to ensure suppliers are appropriately entered into the QMS and that they are re-evaluated as required per QMS requirements.

Performs other duties and responsibilities, as assigned.

Essential Qualifications:

Education: Bachelor's degree

Experience: Minimum 4 years relevant work experience in the medical device industry

Desirable Skills:

· Familiarity with medical device quality system regulations as defined in ISO 13485 and 21 CFR 820.

· Ability to work independently and in a cross-functional team environment in an on-site and remote capacity with minimal direction

· Located within driving distance of the San Clemente office