Description:
The Design Assurance specialist role supports design assurance throughout the product lifecycle. Design Assurance works with the development / engineering teams to ensure that devices are designed in accordance with product requirements as well as ISO 13485, ISO 14971 and 21 CFR 820 requirements.
Duties and Responsibilities:
DA Responsibilities
- Works closely with engineering and quality assurance to ensure quality records are complete – performs review of all quality records for requirements of SP0023
- Assists engineering and quality assurance with product development project tasks as assigned
- Contributes to project design and development documentation deliverables
Document Control
- Understand and apply Documentation and Record Retention principles and processes to ensure compliance with regulatory requirements
- Assist with necessary administrative roles within Grand Avenue for document control as needed for the engineering group
- Maintenance of project related Design History Files, as required
Quality Systems
- Review quality records, including lot history records, inspection forms and returned product records to ensure GDP requirements are met
- Provides Quality Systems training for incoming engineering team members
- Grand Avenue basic training
- DCR prep training
- Documentation / GDP basics
