Document Control Specialist

The Document Specialist/Document Specialist II reports to the Manager, Quality. They will own the document control process including providing training and coaching to all users of the ePLM system through the entire product development cycle. Our client is an exciting, innovative, well-funded engineering startup targeting first-in-class medical device design, located in the greater San Jose-Santa Cruz, CA area.

All qualified candidates must be authorized to work in the US without the need for employer sponsorship.

Responsibilities include:

  • Manage document workflows within the electronic product lifecycle management (ePLM) system
  • Track change orders from creation through release
  • Create and execute training programs for users of the ePLM system
  • Participate in document control improvement activities i.e. updating SOPs, forms, and templates
  • Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings
  • Control and manage external standards (design and deliverables) to ensure compliance with all relevant US FDA requirements
  • Establish and maintain a dashboard summarizing/updating quality system process metrics

Requirements:

  • BA/BS with 5+ years work experience in a regulated healthcare industry segment (medical device, biopharma, diagnostics) in a document control role
  • Experience with following quality processes governed by regulatory standards i.e. 21CFR820 and ISO 13485
  • Excellent organizational and time management skills
  • Experience with key systems such as Microsoft Office and ePLM/eQMS systems and the ability to manage documents within relevant systems
  • Demonstrate initiative, a collaborative orientation and strong communication skills

Apply Now