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OraSure Technologies Inc.

Posted 18 days ago

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Quality Assurance Associate

CambridgeOn-siteFull-time

AI Summary

Quality Assurance Associate ensures compliance with FDA, ISO and medical device regulations; reviews documentation, participates in CAPAs and quality events, and supports continuous improvement of the Quality System.

About this role

Sherlock Biosciences based out of Cambridge and Oxford, UK, is a wholly owned subsidiary of OraSure Technologies Inc. (OTI), and enables the democratization and decentralization of testing to personalize healthcare and make an impact on global health. OTI empowers the global community to improve health and wellness by providing access to accurate, essential information. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market.

Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions.

Overview
Here at OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease.

SUMMARY

Individual will be responsible for performing quality assurance functions related to ensuring compliance to applicable FDA, ISO, and Canadian Medical Devices, and other country regulatory agencies requirements applied to currently approved products and products under development.

Essential Duties and Responsibilities

  • Review and approve documentation for in-coming raw materials and manufactured products to ensure compliance with the Quality System requirements, including archiving of Device History Records, in accordance with established document retention policies
  • Assist in quality events (CAPAS, root cause analysis, etc.)
  • Participate in the preparation and review of documents and procedures supporting compliance to Quality System requirements
  • Participate in evaluating Quality functions to ensure continuous improvement of the Quality System
  • Other tasks as assigned

    • Qualifications

  • Strong planning, organizational and time management skills
  • Able to handle multiple projects simultaneously
  • Attention to detail, and good problem-solving skills
  • Self-motivated and able to work with minimum supervision
  • Well-developed communication skills both written and oral

    • PHYSICAL REQUIERMENTS

  • Ability to work at least 40 hours in an office environment, flexible to work overtime as needed
  • Ability to follow written and oral directions, good communication skills
  • Ability to use office equipment
  • Ability to perform general mobility functions (e.g., sitting, bending, standing, filing, light lifting)

    • EDUCATION AND/OR EXPERIENCE

  • Any scientific degree with 0-2 years of experience in a regulated industry
  • Well-developed PC skills, knowledge of Microsoft applications (Office, Excel, etc) or equivalent required

    • Skills

    CAPAContinuous ImprovementDevice History RecordsDocumentation ReviewDocument ControlFDA Regulatory ComplianceISO 13485Microsoft Office (Excel, Word)PC SkillsProceduresQuality AssuranceQuality InvestigationsQuality Management SystemRegulated Industry ExperienceRisk ManagementRoot-cause AnalysisValidation

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