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Quality Documentation Administrator/Document Controller
4 weeks ago
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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