Provide support to engineering, production, accounting, sales and quality while adhering to the quality system requirements. This position is responsible for initiating, improving and maintaining the engineering documentation system and contents while identifying continuous improvement projects pertaining to the engineering document system. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.
This is a temporary 4-6 month position, with the possibility to transition to permanent employment depending on business conditions.
- Manage the day to day requirements of the engineering documentation system, through:
- Engineering Change Orders
- Manufacturing Change Requests
- External standard control (ie. ASTM, ISO)
- Records Management
- Documentation Life Cycle (creation, revision, obsolescence)
- Provides training and guidance
- Work with product development teams to ensure compliance when transferring documents to the Engineering Document System, make recommendations to properly structure, develop and transfer the documentation
- Utilizes on site systems to control hard and electronic copies of documents for example: Item Masters, BOM's, Routers, Travelers, Manufacturing Change Requests, Device Master Records, Inspection Plans, External Standards
- Identifies improvements for coordinating usage of the documentation systems
- Creates and Maintains processes for documentation system requirements.
- Represent Engineering Documentation needs in cross functional teams as assigned
- Maintain compliance to procedures and regulatory requirements.
- Understand and follow safety policies and practices, attend safety training and wear PPE as required
- Maintains and prepares project plans to satisfy timeline requirements
- Performs Corrective and Preventative Action tasks
- Misc items may include: System Log Maintenance, ECO Creation, Engineering form(s) and Template(s) control, BOM entries, ERP System data entry, Creates / designs forms for improving data accuracy and ease of entry, reviews and finalizes pre-release documentation.
- Other Duties as assigned.
BASIC QUALIFICATIONS / EXPERIENCE:
- FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
- 3 Plus years' experience in the quality/engineering/manufacturing environment for medical devices related to documentation control
- Strong computer skills associated with Microsoft software
- Must be able to read, write and speak fluent English.
- Excellent reading, writing, communication, and organizational skills.
- Maintains performance with changing priorities under minimal supervision
- Possess team collaboration skills
- Must be able to make clear and accurate decisions
- Proven history of pursuing and driving changes
- Minimum of Associates degree.
- Prefer education in a technical discipline or related field.
Sthree US is acting as an Employment Business in relation to this vacancy.