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
Requirements 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.
- 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
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- 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.