Job Description
Position Summary:
The primary purpose of this position is to support 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 & Experience : Bachelor’s degree & Minimum 2 years relevant work experience in the medical device industry or 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
Job Tags
Work experience placement, Remote job,