Quality Inspector

1. General Information
  • Department Name: Quality
  • Reports to: Quality Manager
  • Supervises: N/A
  • Exempt/Nonexempt: Nonexempt

2. Essential Duties and Responsibilities

A. Acceptance Activities

  • Ensure that finished devices consistently meet required quality standards based on documented requirements
  • Implement quality methods; drive the use of quality tools in manufacturing, assist in resolving quality issues.
  • Develop and implement methods and procedures for disposition of discrepant material
  • Inspect all incoming materials for use in manufacturing of medical devices, evaluate quality of materials and determine acceptance or rejection of these items based on documented requirements
  • Inspect purchased items and subcontracted parts and sub assemblies intended for use in medical device manufacturing processes or systems based on documented requirements
  • Inspect finished goods and release to inventory based on documented requirements
  • Inspect device history records to ensure compliance with procedural and regulatory requirements prior to release of finished goods
  • Review, write and revise quality control specifications or acceptance criteria as needed and generate required supporting documentation to implement the revision
  • Document and communicate results of acceptance activities per approved and applicable Quality System procedures, forms and/or other documents

B. Quality and Business Systems

  • Identify solutions and/or complete assigned tasks related to resolution of corrective and preventive actions, internal audit findings and non-conformance reports
  • Schedule and provide assistance to complete critical tasks required to maintain the Quality System, e.g.: calibration, particulate monitoring, etc. Update processes and methods as needed to improve the effectiveness of the systems
  • Monitor, trend and evaluate results of quality monitoring processes including bioburden, pyrogen and NCR trend data. Evaluate and investigate as necessary results of monitoring process and communicate the information in appropriate formats including basic statistical summaries and trend charts
  • Monitor supplier status and communicate any change in status to the finance, quality and operations department heads. Generate and maintain approved supplier files, including audit documents and supplier performance metrics=

C. Document Control

  • Provide assistance and guidance to manufacturing, quality, purchasing and receiving personnel in the execution and routing of controlled documents for approval in the electronic document management system
  • Identify and implement changes to Quality System documents per existing change control procedures to improve document clarity or enhance compliance of the document to procedural and/or regulatory requirements
  • Maintain quality documentation files for device history records, suppliers, calibration, maintenance, internal audits, environmental and product monitoring activities

3. Responsibility and Authority Affecting Quality
  • Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System
  • Identify and record potential problems relating to the product, process and Quality System
  • Initiate, recommend or provide solutions through designated channels
  • Verify the implementation of solutions
  • Perform basic statistical analysis and communicate results to Engineering

4. Position Requirements

A. Skills and abilities (required for the job)

  • Excellent communication skills
  • Excellent writing skills
  • Strong organizational skills
  • Detail oriented
  • Ability to handle multiple tasks simultaneously
  • A team player
  • Ability to read and interpret technical specifications and blueprints
  • Ability to maintain accurate records
  • Ability to use common incoming inspection equipment, such as calibrated micrometers, depth gauges, rulers, microscopes, etc.
  • Basic statistical knowledge, able to calculate average and standard deviation

B. Education, experience and training (required for the job)

  • Associate’s degree or equivalent
  • Five years of experience, or equivalent
  • Training in FDA QSR, ISO 13485:2003 and CMDCAS
  • Basic computer skills, i.e. Word and Excel

C. Working environment

  • Work station area: Office
  • Special factors in the work area: None
  • The working environment is indoors and seasonally heated and cooled with minimal noise levels.
  • The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
  • The position requires the ability to communicate in person, telephonically and via email.


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