Documentation Control Specialist

  • location: Cayce, SC
  • type: Permanent
  • salary: $55,000 - $65,000 per year
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job description

Documentation Control Specialist

Permanent position: Document Control Analyst needed at leading manufacturing plant located in West Columbia, SC. This is a day shift role. APPLY NOW!

Responsibilities for the Documentation Control Specialist
  • Ensures projects are in compliance with document control policies and procedures.
  • Ensures data accuracy and completeness of documentation including logs, reports and distribution.
  • Manages and tracks product configuration and manufacturing/customer requirements.
  • Responsible for interface between program manager, engineering, manufacturing and materials to ensure appropriate changes are documented.
  • Collects and reports process performance metrics.
  • Ensures procedures are followed and may develop procedures for the quality assurance inspection operation.
Requirements for the Documentation Control Specialist

  • Associates or Bachelor's Degree or related field.
  • 2+ years of experience in Document Control within a medical device manufacturing environment
  • Experience preparing for external QMS and regulatory audits, audit room manager/coordinator, train and prepare staff.
  • Expertise knowledge level and application of QSR's, LHR/ DHR practices, ISO 13485, and 14971
  • First-hand knowledge of applicable US (21 CFR 820) and ISO 13485 quality system requirements
Benefits

  • Full range of medical benefits, dental, vision
  • Life Insurance
  • Matching 401K
  • PTO
  • Tuition Reimbursement
  • Employee discounts at local retailers
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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