Job Details
Title: Quality Engineer - Onsite
Description:
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
Notes:
9 am-5 pm, but flexible for core hours (8 am-4 pm)