Excellent Quality & compliance opportunity within a growing business in Cork
I am currently working with a Health care company who are in a high growth phase. Their success is driven by staying close to the customer and being willing to go the 'extra mile'. Due to this recent growth there is a permanent opportunity for a Regulatory, Quality & Compliance Coordinator to join their team.
This role will report into the Quality Manager and will oversee and manage the compliance program in collaboration with the Quality and Regulatory team. In summary the individual will be involved in developing, initiating, maintaining, and revising policies and procedures for the general operation of the quality compliance program.
Key elements of this role:
- Manage product complaints, maintain a product complaint control sheet and communicate details of complaints to the relevant departments and regulatory bodies
- Support product recalls / notifications, maintain a product recall / notification control sheet and communicate details of Field Safety Notices to the relevant departments and regulatory bodies
- Review and update regulatory procedures across the business
- Liaise across the business in reviewing and improving processes, standards and delivery of specific projects as required
- Assist in the successful completion of Quality audits, including ISO9001 and HPRA audits
- Generation of KPIs, reports and minutes for Quality meetings
- Ensure product compliance with EU legislation
- Assist with organising and recording training regarding the quality system, applicable standards and regulations across all departments
- Conduct internal departmental audits as required
Key personal requirements
- Regulatory, Quality and / or Compliance background
- Experience of working in a fast-paced, highly pressurized environment
- Experience in dealing with regulatory bodies would be an advantage
- Experience working in a Medical Device company would be a distinct advantage
- Experience working with ISO 13485, ISO9001 and ISO14001 Quality Management Systems would be a distinct advantage:
If you are comfortable working to deadlines, working cross functionally and have strong attention to detail and would like the opportunity to work in a growing organisation the 'apply now' and I will be in touch. If you would like to find out more I can also be contacted on firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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