Document Control Specialist
Document Control Specialist
Documentation Control Specialist
- Ensure compliance with the organization’s policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO) regarding Documentation Control. Work with R&D, Manufacturing, Product Support and Marketing to improve product quality to meet current cGMP standards.
- Develop and maintain standard operating procedures (SOPs). Review ECOs and other documents for accuracy, approve and reject tasks, notify initiator/author when training can be completed. Review and process as needed manufacturing/test procedures for products and raw materials for release into inventory and shipping. Organize and track the training program for all employees.
- Create and maintain BOMs and item master in XA
- Maintain records and indexes of all documents stored off-site.
- Assure all 510(k)s, DHF, Validations and master document files are in a locked, controlled environment, with access limited to Document Control employees and other department officials on an as needed basis.
- Prepare materials as needed for 3rd party audits and maintain objective evidence documents.
- Update management with bi-weekly and quarterly metrics as defined by the QA Manager.
- Other duties as assigned.
- Must be able to work with minimal supervision from management. Excellent ability to collaborate to achieve objectives and problem-solve. Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices. Understanding of various software programs required to document existing and new documentation.
- Able to handle highly confidential messages and correspondence.
- Must possess outstanding communication (verbal and written), interpersonal, problem solving and customer service skills.
- Detail-oriented with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
- Must be self-starter, able to prioritize and handle multiple tasks and ability to meet strict deadlines and perform under pressure in a fast-paced work environment.
- Good problem solving and troubleshooting skills.
- Able to read, understand and follow company Standard Operating Procedures (SOPs) and guidelines.
- Must be able to work overtime and weekends as necessary to support departmental efforts.
Minimum Qualifications / Education:
- High school diploma or equivalent (GED) is required.
- College education in a business-related field is desirable.
- 3+ years QA experience with a medical device or IVD manufacturer
- 3+ years in a Documentation Control position.
- Experience with electronic Quality Management Systems a plus.
- Excellent computer proficiency with Microsoft Office Suite (Word/Excel/PowerPoint/Outlook)
- Electronic Quality Management System Software.
- MasterControl experience is not required but would be beneficial.
- Experience with Autocad, Solidworks is a must
Work Environment: Office
Physical Requirements: Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.