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Quality Associate/ Specialist

LanceSoft INC
Boston, Massachusetts, United States
April 10, 2019


Position is for a Quality Associate/Specialist


Responsible for submitting DCRs to remediate process documents to align with FDA requirements.

Responsible for generating reports as needed associated with status of PMA project, DCRs pending, completed.

Provide updates to management and project team as needed.

Escalate issues appropriately and quickly if any updates will not be completed per the schedule set forth.

Tracking document and process changes to closure associated with PMA.

Reviewing DCRs submitted by site personnel to support PMA project.

Scanning documentation associated with PMA project and validations to support FDA submission.


Quality Associate/Specialist with Document/Change Control experience preferred.

B.S. Degree in Science or Engineering.

Minimum 2-3 years’ experience in any Quality related function.

General Quality knowledge associated with medical device or Pharmaceutical related industries.

Excellent writing and communication skills.

Proficient in Microsoft Suite products, word, excel, etc.