Quality Documentation Coordinator

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Quality Documentation Coordinator

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    Quality Documentation Coordinator
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    Direct Hire
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Are you energetic, well-organized and thrive off of solving issues for clients directly? The DAVIS Companies has partnered with a leader in the medical device industry by securing a Quality Documentation Coordinator to join their team. This position is responsible for providing quality support to a designated internal team by performing documentation review and audit support. An ideal candidate will have the ability to successfully multi-task and adapt to change in our fast-paced, dynamic environment.

Job Summary

  • Monitor sterilization and testing requirements/events for customers (dose audits, bioburden testing, etc.)
  • Provide support for customer audits, questionnaires, complaints, NCR's, CAPAs, and quality system information requests.
  • Provide team guidance related to meeting the Quality Management System.
  • Perform customer-related document change request (DCR) reviews for meeting the companies system and the customer requirements.

Skills and Experience

  • CAPA Management and problem-solving skills using QA tools
  • Skills and knowledge equivalent to those obtained in a technical program or certificate related to the Quality Field with a minimum of 3 years work related experience.
  • Knowledge of blue print reading and a basic understanding of dimensions and tolerances.
  • Experience with ISO Quality Systems, ISO 13485 training and experience preferred
  • Internal Audit Experience, CQA preferred
  • Familiar with sterilization processes and direct customer interaction

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