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Quality Audit Coordinator

4 months ago

Doylestown, United States Insight Global Full time

Must Haves:

  • 3+ years experience in a quality related role in a manufacturing environment
  • Experience engaging in quality audits or investigations
  • Experience with quality documentation control
  • Strong written and verbal communication

Plusses:

  • Background in medical device industry (or other regulated industry)
  • Bachelor’s Degree
  • Strong root cause analysis (i.e. Flow charts, fishbone, six sigma, 5-Why, 8D, DMAIC)
  • Strong knowledge and understanding of ISO standards (ISO 13485 is preferred)

Day to Day:

A Medical Device packaging company in the Trevose, PA area is looking for a CAPA Coordinator. This person will have a hybrid of quality and customer service responsibilities. This person will act as the administrator of the customer complaint process. They will need to intake and manage customer complaints in an effective and orderly manner. Ensuring that there is proper documentation and that proper investigation performed to validate the customer complaint. This person will need to work cross functionally with various teams within manufacturing to conduct investigations, as well as assist in the implementation of necessary corrective action. They will need to ensure that the quality department is always audit ready and that documents are properly filed. This role will require very strong written and verbal communication, as it will involve both customer and internal communication.