Quality Assurance Specialist

ESSENTIAL FUNCTIONS:

  • Internal Auditing- responsible for planning, conducting, distributing and following up on internal audits in accordance with existing procedures.
  • Inspection – Assist with incoming and in-process inspection activities as required.
  • Corrective and Preventative Action System/Nonconformances- responsible for maintaining an effective methodology for capturing nonconformances, corrective/preventive actions and customer complaints. Ensures proper follow-up is performed to demonstrate compliance to existing procedures.  Graphs and reports on status of corrective actions/nonconformances on a periodic basis in support of management review.
  • Supplier Quality- responsible for the qualification of external suppliers in accordance with existing procedures. Responsible for conducting, documenting and following up on external audits.  Responsible for responding to customer and end user quality surveys.
  • Training- plans, schedules and conducts technical training on the quality system and related elements (in accordance with the Training Plan). Responsible for the procedural structure and coordination of company training.  Ensures systems are in place to maintain the integrity of systematic training on an ongoing basis.
  • Customer Interface- Communicates with customer /end user to handle product compliance inquires and follow-up on customer requests.

OTHER RESPONSIBILITIES:
Performs other duties as assigned by supervisor.

The above statements are intended to describe the general nature of work being performed by people assigned to this job.  They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel classified under this job title.

JOB SPECIFICATIONS:

  • Knowledge of ISO9001, USP 87, USP 88-Class VI, FDA 21 CFR 174.5, 110, 210, 820
  • Strong written/verbal communication skills.
  • Strong PC skills to include word processing, spreadsheet and database.
  • Capable of using standard quality measurement devices (calipers, durometers, micrometers, etc.)
  • Capable of reading basic blueprints, sketches, specifications
  • College Degree

MAXIMUM WEIGHT TO BE LIFTED:  35 lbs . (anything over 35 lbs requires two people or mechanical device)

POSTURE: Sitting, Standing

WORKING CONDITIONS: Office and some warehouse activity

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