Our client, the leading maker of customized orthopedic implants, has an immediate need for Document Control Coordinator (DCD). The DCD is responsible for supporting the regulatory team by managing the daily document control system. DCD assists with the maintenance and processing of documentation, provides quality system support to all departments within the company, maintains Device Master Record and Device History Records as part of the quality system, and maintains department databases.
- Develop and maintain strong internal working relationships across the company
- Understand the objectives, responsibilities, and mission of the Regulatory department and work towards those goals
- Prioritize and plan work activities; adapt for changing conditions
- Administer changes to documents in accordance with company requirements
- Track all routing and approval stages
- Create/modify Microsoft Excel documents.
- Ensure new documents and records are consistent with company procedures
- Review documentation for accuracy, completeness, and consistency in content, format, files, and approvals
- Manage external standards, controlling quality records, compiling data, and generating requested reports
- Maintain training system
- Maintaining quality of internal and external records
- Conduct data collection and entry
- Review labels for accuracy and precision.
- Review of Device History Records to perform release of sub-assemblies and finished goods on an as-needed basis.
- Provide support to incoming inspection on an as-needed basis.
- Other responsibilities as assigned
- Associates Degree in a technical field or equivalent experience
- 1-3 years of experience in Administrative or Clerical role
- Experience with technical documentation, medical device or manufacturing environment preferred
- Proficiency in Microsoft Office
- 18 months or more of Quality Assurance and experience in a FDA regulated environment is preferred – with QSR (21 CFR Part 820) experience if possible.
- Understanding of cGMP, GDP, ISO 13485.
- Oracle experience a plus.
- Excellent written and verbal communication skills
- Working Knowledge of Formulas in Microsoft Excel
- Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
- Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
- Strong organizational, analytical, and time-management skills
- Able to self-motivate and work both independently and as part of a team
- Ability to plan, organize, and multi-task to meet deadlines
- strong attention to detail
- Perform responsibilities under minimal supervision
- Experience in FDA Regulated environment preferred
- PLM software (Agile/SAP) experience a plus
- ERP/MRP (Oracle/SAP) experience a plus
- Ability to lift, push, and pull up to 50 lbs.