Design Assurance Specialist

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