Job Detail

Location Sligo
Salary Negotiable
Posted
Role Type Fixed Term Contract
Contact Clara Burke
email science@hero.ie

Quality Systems Lead

Quality Systems Lead

New opportunity for a Quality Systems Lead to join a well established Sligo based multinational. In this role you will be responsible to ensure compliance with organizational and regulatory requirements.

Key Responsibilities:

  • Take steps to improve the site Quality Management System continually
  • Be proactive and diligent in ensuring adherence all site ISO certification and Regulatory Status including ISO 13485
  • and MDSAP Certification
  • Provide effective and responsive Quality support to other departments to ensure they meet their objectives for quality, cost, and output
  • Lead and champion the site audit readiness program
  • Ensure all Medical Device Site Quality activities are in compliance with applicable regulations
  • Approve change requests for product, process and quality system changes
  • Investigate and trend Customer complaints
  • Perform CAPA activities, as required in addition to the investigation of root cause analysis, CAPA generation and effectiveness monitoring
  • Preparation and approve validation plans, protocols, and reports
  • Compile required regulatory documentation (e.g. Technical Files, Design Dossiers, Product transfer files, Essential requirements documents)
  • Perform internal and external (vendor) quality audits
  • Support the transfer of products and processes from development or another manufacturing facility through to production on site
  • Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities
  • Provide technical leadership to functional areas and collaborates with key stakeholders
  • Lead and develop team members including performance management, developing training plans and performance reviews

  • Qualifications

  • Degree in Science/Engineering/Quality
  • +5 years’ experience in a similar role
  • Green Belt Qualification would be highly desirable.
  • Must have expert knowledge of Regulations, ISO13485, MDD, FDA CFRs, Medical Device Standards
  • Experience of Internal and External Audits. Must have Auditing Qualification
  • Must have experience audit facing FDA/Notified Body audits

For further information on this role please contact Clara Burke on 086 816 8273/ science@hero.ie  



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Clara Burke

JOB-11407

Quality Systems Lead

Clara Burke

Role Type Fixed Term Contract
Contact Clara Burke
email science@hero.ie
mobile +353 86 816 82 73
linkedIn profile click here

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