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

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