6Q02 - Quality - QAEN - QUALITY ASSURANCE ENGINEER

Inteplast Group-posted 6 months ago
Full-time • Entry Level
Gallaway, TN
Plastics and Rubber Products Manufacturing
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The Quality Assurance Engineer assists the Quality Assurance and Regulatory Affairs Manager in maintaining a regulatory compliant quality assurance department that provides all research, support, product development, and quality assurance functions required along with accurate specifications, service, and delivery of product to customers. The role involves supporting production schedules, personnel, resources, and continuous improvement efforts to achieve efficient service productivity. The engineer also evaluates and controls vendor reliability of goods and services.

  • Develop and maintain a comprehensive and compliant quality management system for medical products in FDA product device classes I and II.
  • Ensure compliance with various regulatory agencies and regulations, specifically the FDA and Health Canada.
  • Assist in the compliance and maintenance of the quality management system.
  • Provide quality engineering functions to ensure products meet their intended use through specification, evaluation, and data analysis.
  • Conduct company-wide training in statistical techniques and quality science.
  • Direct technical and administrative personnel engaged in quality assurance activities.
  • Evaluate and provide audits, corrective actions, preventive actions, and compliance verification of quality management systems.
  • Investigate and maintain records for customer complaints with root cause analysis and corrective actions.
  • Act as a quality representative for customers and vendors.
  • Assure validation and compliance of medical device products through contract sterilization facilities.
  • Perform other duties as assigned by the Quality Assurance and Regulatory Affairs Manager.
  • Bachelor's degree in industrial engineering, mechanical engineering, or business from an accredited four-year college is preferred.
  • Associate's degree or equivalent from an accredited two-year college/technical school, or higher will be considered, plus 2-4 years of quality assurance engineering experience in a medical device manufacturing environment.
  • Experience in Plastic Injection and/or Blow Molding is desired.
  • Working knowledge of the FDA 21 CFR Part 820 Quality System Regulation.
  • Working knowledge of ISO 13485:2016 Standard is preferred.
  • Current certified ISO 13485:2016 Lead Auditor certificate is preferred.
  • Computer literate in Microsoft Office suite and experience with database systems.
  • Proficiency in SAP is a plus.
  • Ability to apply common sense understanding to carry out detailed written or oral instructions.
  • Ability to manage job-related stress and foster productive workplace interactions.
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