Medicom Consulting

Responsibilities

• Establish a functional quality management system to meet various US and EU medical device regulations and quality policy of the company.
• Ensure the quality management system obtains certification by designated Notified Body to allow sale of product in the EU
• Submit device technical file to Notified Body for review and approval
  Ensure DMR is transferred to the Ireland, UK and Puerto Rico manufacturing facilities of the company
• Ensure all manufacturing activities are appropriately controlled and processes validated.
• Participate in complex project management relating to the international coordination of activities at manufacturing facilities in Ireland, UK, Puerto Rico and the USA.
• Provide personnel development and mentoring services
• Communicate with senior company management on progress and recommend technical, quality and regulatory strategy as necessary.

Achievements

• New Manufacturing plant set up in Ireland with supporting facilities in UK and Puerto Rico on time and within budget to manufacture and distribute finished product.
• Quality management system approved without problems at initial Notified Body inspection to meet requirements of ISO 13485:2003 and the MDD 93/42/EEC
• FDA Facility registration
• UL Registration.
• Handed over facility in excellent state of control to newly hired management, and thanked by senior corporate management for a project well delivered.