Quality Associate Job at AtaCor Medical, Inc., San Clemente, CA

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  • AtaCor Medical, Inc.
  • San Clemente, CA

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,

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