Collins McNicholas

Role Responsibilities:

  • Establish, maintain and continuously improve the company’s quality systems, procedures and policies
  • Maintain design history files in accordance with the company’s product development process
  • Liaison with the Notified Body, FDA and Competent Authorities as required
  • Lead CAPA related activities and associated tasks.
  • Manage company’s preventative maintenance and calibration schedules and plans.
  • Ensure product inspections take place in line with company procedures, manage any Deviations, NCPs or MRBs which may arise.
  • Prepare for and document company meetings such as Management Review, Post Market Surveillance and Quality Monthly Meetings.
  • Manage task completion as they arise from company meetings.
  • Trend all Quality Data as required, identify and implement changes or improvements to existing systems.
  • Manages, plans and documents all routine product testing to ensure continued compliance of products
  • Management of Internal auditing programs and vendor management activities including critical vendors audits
  • Act as management representative with responsibilities as outlined in ISO 13485, clause 5.5.2
  • Manage and drive project tasks to ensure timely completion of QMS project milestones.
  • Support regulatory affairs activities in support of medical device product development, including clinical, preclinical, and marketing issues
  • Monitor global regulatory/quality system changes, guidelines or trends, complete gap analysis plan, advise or implement changes to ensure compliance.
  • Lead the integration of the EU MDR requirements into the existing ISO 13485 Quality Management System.

 

Role Requirements:

  • Degree qualified with a minimum of 10 years’ experience in quality role of a medical device company
  • Established understanding and track record of ISO 13485, 21CFR820, ISO 14971 and MDD93/42/EEC
  • Ideally have knowledge of requirements of the new European Medical Devices Regulations (EU-MDR), Regulations (EU) 2017/745.
  • Lead auditor certification (IRCA or ANAB)
  • Experience of clinical trials or clinical investigations would be beneficial
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem solving, oral and written communication skills
  • High level of self-motivation and detail oriented to deliver assigned tasks
  • Ability to work as part of multi-disciplinary team of clinicians, engineers and senior management

 

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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