Description

Description:

  • This position is responsible for performing change controls, creating and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System.
  • Assists with the analysis of data for quality management system metrics, regulatory activities and supports quality management system projects and tasks.


Description of Work:

  • Generates, reviews, and maintains division level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
  • Initiates Change Controls and Document Change Requests to update procedures and processes. Collaborates with manufacturing and distribution sites to assess the impact of changes to site level processes.
  • Assists with monitoring and assessing quality system metrics to ensure maintained compliance.
  • Acts as a lead auditor for division internal audit program.
  • Assists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
  • Supports or leads continuous improvement initiatives for quality management system processes.
  • Assists with regulatory activities.


Minimum Qualifications:

  • Bachelor’s Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).
  • Master’s Degree, 1+ years of work equivalent experience (work in a manufacturing environment is preferred).

Skills/Experience:

  • Previous experience using ETQ software preferred
  • Proficiency in Microsoft office
  • ISO 13485 and 21 CFR 820 Quality Management Systems knowledge
  • Internal auditor experience and/or training
  • Must be detail oriented and accurate
  • Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
  • Ability to work across matrix organizations and external consultants.
  • Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary

Key Skills
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