Quality Documentation Administrator/Document Controller

4 weeks ago


Newton, United States Cube Hub Inc. Full time

Description:


Duration 3 months contract

Location Newton MA

Onsite


Responsibilities:

• Disposition non-conforming material (NCMR).

• Lead and/or participate in product complaint investigations leading to root cause.

• Propose, lead, initiate and follow-up on Corrective Action and Preventive Actions (CAPA).

• Ensuring that all changes and associated documents are managed in accordance with internal and external standards, policies, and procedures.

• Ensuring the accuracy (Quality) of documents with regards to: numbering formatting, revisions, and content per approved changes.

• Incoming part inspection; ~ 70% Mechanical, 30% Electrical.

• In-process Inspection.


Required Knowledge/Skills, Education, and Experience

• HS diploma/GED

• 2-5 yrs. combined experience of Document Control, Inspection, and/or Quality Assurance experience

• Working knowledge of SAP PLM (1-2 yrs.)

• Proficient with MS WORD and EXCEL

• Strong organizational skills, detail oriented, and the ability to meet changing deadlines on a fast-moving environment

• Ability to communicate effectively within a technical environment

• Team player who is customer driven

• No travel required.


Preferred Knowledge/Skills, Education, and Experience

• Prior Medical Device/Biotech experience

• Prior experience with a Document Control Platform such as Arena or Agile

• Ability to work semi-independently within a regulated environment



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