Amick Brown is looking for an experienced Design Validation Coordinator for our direct client
Location:Santa Clara, CA Duration: 8 Months
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
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: