Technical Quality Assurance

2 weeks ago


Zelienople, United States Compunnel Full time
Job Description:

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 Client 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

Additional client information:

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