May 19, 2021

Lead Quality Assurance Documentation Control Specialist

  • Cue Health
  • Sorrento Valley, San Diego, CA, USA
Full time Quality

Job Description

Cue Health Inc. is seeking to hire a full-time Lead Quality Assurance Documentation Control Specialist Reporting to the Quality Management System Manager, the Quality Assurance Documentation Specialist will provide support in electronic Quality Management System (eQMS), documentation control, training and administrative supporting Cue Health’s Quality Management System. Responsibilities: Lead the Document Control team Provide support to maintain the Quality Management System in accordance with US FDA Quality System Regulation and ISO 13485 Act as principal administrator for Cue Health’s eQMS Implement eQMS system and coordinate with other teams as needed for implementation Ensure eQMS compliance to ISO13485, 21CFR820, 21 CFR Part 11 Work with Cue Health’s departments for the implementation of the eQMS Provide trending on eQMS, document control and training processes Maintain and facilitate the Change Order System and Document Control System Support the training program and provide trainings on eQMS and Quality Management System to Cue Health’s employees Support the collection, maintenance, and storage of Quality System and medical device product records including Device History Records (DHR), manuals, procedures, work instructions, forms, Design History File (DHF) and Device Master Records (DMRs) Update and maintain Quality Databases Support the design and update labels and labeling Work with Marketing on website updates and change control Assist in audits and publish audit reports (Internal and External) Assist QA management with special projects or other duties as assigned Requirements: 5+ year work experience in Quality Assurance Medical Device Field as Documentation Specialist or equivalent role Significant experience in implementing, administrating, and supporting eQMS Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc. to perform critical job functions, trending, reporting metrics etc. Knowledge of ISO13485 and 21CFR820 Be an independent, self-starter with exceptional communication (written and verbal) skills, detail oriented, organized, and able to prioritize and balance workload in a fast-paced and dynamic environment Demonstrated evidence of a solid background of eQMS, documentation control knowledge and experience combined with the proven ability to successfully deliver projects and influence people at all organizational levels Utilize critical thinking skills to problem solve and troubleshoot Internal and external auditing experience, a plus Experience as trainer Bachelor's degree from four-year college or university, preferred Analytical performance testing a plus Must be available to work hours outside the normal workday as needed You will work in a Office environment. Your contribution will set the pace and have an impact in the technology, health and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, competitive salary.

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