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Design Validation Coordinator

Santa Clara, CA
Amick Brown is looking for an experienced Design Validation Coordinator for our direct client

Location: Santa Clara, CA
Duration: 8 Months

Job Description
  • We are seeking a Design Validation Coordinator to support software product development projects, with an emphasis on documentation deliverables and data entry.
  • The Coordinator will identify, track, and facilitate SOP requirements and activities to ensure Design Control and Computer Systems Validation compliance, including working with traceability and document database tools.
  • A large responsibility is deliverables review with high attention to detail, as well as deliverable tracking and coordinating the writing and release of documentation during the design phase.
  • Must be proactive, detail-oriented, and possess strong communication and time management skills.
Roles & Responsibilities:
  • Post-execution review of test scripts in HP-ALM. This task requires strong focus, patience, and attention to detail.
  • Initiate and track ECOs in Agile (ACCS), including drafting change description and other technical writing/administrative tasks.
  • Monitor and succinctly report status: milestones, risks, action items, and deliverables
  • Coordinate activities defined by the project Validation Lead
  • Import and manage documents and traceability in ALM systems (Jira / Polarion / zQMS); significant data entry responsibilities
  • Set up Design History File (DHF) structure; work with team to ensure DHFs are updated and accurate
  • Liaison with Document Control and ECO Change Control Board (CCB)
  • Other responsibilities as assigned
Required Skills:
  • Minimum Bachelor’s Degree required, technical field preferred
  • Good organizational and investigative skills; proactive problem solving
  • Excellent verbal and written communication skills
  • Ability to quickly switch between many different projects
  • Familiar with waterfall and SCRUM project management
  • Solid understanding of Quality Systems or Design Controls for Medical Devices and SDLC
  • Solid understanding of Good Documentation Practices (GDP)
  • Proficient in Word, Excel, PowerPoint, Project, Smartsheet, or other similar tools
  • Proficient in ALM tools (such as MKS/PTC Integrity or Polarion), Oracle/Agile, HP-ALM, and JIRA
  • Specialized training in a discipline such as computers and/or planning and scheduling
  • Data entry and traceability management experience desired
  • Please submit a technical writing sample along with your resume.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.

Regular full-time employees are eligible for the following Amick Brown provided benefits:
  • Health
  • Vision
  • Dental
  • 401k with company match
  • Paid time off
  • Sick Leave
  • Short-Term Disability
  • Life Insurance
  • Wellness & Discount Programs

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