Tech 2, Quality Assurance
Company: LanceSoft Inc
Location: Zelienople
Posted on: January 27, 2023
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Job Description:
Daytime hours
Job Description Summary
This position is responsible for conducting routine inspection and
analysis of incoming service material and quality reviews of
domestic and international service records by identifying
conflicts, dependencies, and risk of release to ensure Quality
Assurance Standards and procedures are met.
Qualifications
--- Excellent communication and team skills as well as a keen
attention to detail
--- Associate Degree in a related technical field or equivalent
experience
--- Working knowledge of Microsoft Office Suite, Excel, Word,
etc.
--- Operate to the requirements of FDA 21 CFR Part 820 and ISO
13485
--- Basic understanding of Good Manufacturing Practices (GMP) and
Quality System Regulations (QSR)
--- Familiar with a variety of measurement equipment
Responsibilities
--- Ensure compliance of purchased parts delivered to Service
--- Utilize basic measurement tools to inspect parts (Micrometers,
calipers, height gage, thread gage, scales, pin gages, etc.)
--- Perform inspections, checks, and follow sampling procedures
according to the applicable instructions on products having been
delivered by suppliers before their use in production
--- Process all appropriate paperwork for inspection operations
--- Accept or Reject products as defined in the inspection
instruction/ checklist
--- Accurately document non-conformity when applicable with clear
characterization
--- Material Review Support - May be asked to support investigation
of electrical/electronic or mechanical parts to determine root
causes of failures and to assist with dispositions of failed
parts
--- Process service records for *** Direct and Contract Service
Providers (CSP) by reviewing paperwork for accuracy, completeness,
and correctness
--- Perform Device History Reviews (DHR) and Process Failure Mode
and Effects Analysis (PFMEA) reviews in support of complaint
investigations
--- Perform other duties as assigned
Keywords: LanceSoft Inc, Pittsburgh , Tech 2, Quality Assurance, Other , Zelienople, Pennsylvania
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