CooperCompanies

Quality Assurance Coordinator

CooperCompanies

full-time

Posted on:

Location Type: Office

Location: Falmouth • 🇬🇧 United Kingdom

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Job Level

Mid-LevelSenior

About the role

  • - Manage and maintain quality documents, records, and quality system procedures to ensure compliance and traceability.
  • - Gathering data and reporting on KPIs to measure Quality Management System performance.
  • - Effectively monitor and communicate quality management system performance metrics, reporting monthly trending and supporting Management Review.
  • - Identify Quality Management System-related non-conformances and identify trends that require escalation.
  • - Maintain the Training Matrix and support the Quality Manager with the update of supplier status and Quality Agreements.
  • - Assist with Internal Audits and maintain evidence of follow-up actions.
  • - Support in preparation for and hosting of external audits.
  • - Assist with Corrective and Preventive Action (CAPA) root cause investigations and maintain evidence of follow-up actions.
  • - Support with any other Quality-related investigations and improvements as directed by the Quality Manager
  • - Take part proactively in the QA team and ensure good cross communication between QA team members and those of other departments to meet business demands.
  • - Collaborate closely with cross-functional RI teams to resolve quality issues quickly and avoid disruptions.

Requirements

  • **Knowledge, Skills and Abilities:**
  • - A strong focus on accuracy and thoroughness is crucial for quality work.
  • - Ability to identify issues, conduct root cause analysis, and implement solutions.
  • - Strong written and verbal communication skills to interact with various internal and external stakeholders.
  • - Ability to work collaboratively as part of a quality team and with other departments.
  • - Familiarity with conducting data analysis and reporting statistics.
  • - Knowledge of ISO 13485, FDA 21CFR part 820 and MDSAP is desirable.
  • - Excellent organizational, time management and communication skills are needed to handle multiple priorities effectively.
  • - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) is essential for reporting and documentation.
  • - Expertise in MS Office and Adobe Acrobat is desirable, including the creation of locked, fillable forms in both Word and Adobe.
  • **Work Environment:**
  • - Office environment in a shared workspace
  • - Moving about the site and on the shop floor where care is needed
  • - Nature of work may include long periods of intense concentration, frequent interruptions, multiple tasks and meeting deadlines.
  • **Experience:**
  • - Previous relevant experience in a Quality Assurance or Quality Control role in a regulated industry, medical device preferred.
  • - Experience in ISO13485 quality systems is preferred.
  • - Experience in writing technical documents such as policies, procedures, assessments, and reports.
  • - Experience with document control and GMP
  • **Education:**
  • - Degree level qualification or equivalent.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
root cause analysisdata analysisreporting statisticsdocument controlGMPISO 13485FDA 21CFR part 820MDSAPtechnical writingquality management system
Soft skills
accuracythoroughnesscollaborationcommunicationorganizational skillstime managementproblem-solvingattention to detailcross-functional teamworkadaptability