Quality & Compliance Manager

Competitive
Permanent
Cork
23 Dec 2019
BBBH747889

Quality and Compliance role with a company who are experiencing rapid expansion

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 an experienced Quality & Compliance Manager to join their team.

The Quality & Compliance Manager will lead, develop and co-ordinate the activities of the Quality team and will also take the lead with regards to compliance tasks and projects across the Group. This is a key role within the group and will have an extensive remit which covers regulatory, compliance, Quality Management System (QMS), audits, certifications, continuous improvement, QA culture & people management.

The successful individual will oversee a small team with the majority of them being located in Cork and one individual located in the UK. Due to this set up, the successful individual will need to be comfortable managing remotely. Due to the nature of the business there will be an element of travel required but this will be kept within Ireland and the UK.

Key requirements:

  • Minimum of 2 years Quality Management experience, at minimum Supervisory level, within the Medical Devices sector.
  • 5 + years Quality experience
  • Applied knowledge of ISO13485:20016, ISO9001:20015, CE Marking/Council Medical Devices Directive 93/42/EEC, Guidelines on Good Distribution Practice of Medicinal Products for Human Use
  • Relevant training or experience working within a GDP regulated environment for pharmaceutical storage and distribution
  • Hands-on experience of leading regulatory audits
  • Knowledge of Regulatory Affairs requirements
  • Comfortable being the point of contact for compliance queries and ensure compliance with all accreditation requirements
  • Manage and continuously improve the entire QA Program for the Group
  • Knowledge of/ or applied experience would be advantageous in: MEDDEV Guidelines on Medical Devices Vigilance Systems and Falsified Medicines Directive
  • Must be available for travel to attend business reviews within Ireland, UK & NI.

The successful candidate will need to show a flexible approach to work and be able to enthusiastically embrace change and new challenges. While the company will require flexibility they will also be flexible with your working requirements. This is a dynamic and engaging place to work with no two days being the same so if you are looking for a change that will keep you engaged this could be the role for you.

Touch base today if you would like to find out more about this opportunity on 021 2300 300 or click the 'Apply Now' button below.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

Similar Jobs

xciting position for a Compliance Senior Manager, in a Multinational Company leader in Dublin
Dublin15.01.2020
xciting position for a Compliance Senior Manager, in a Multinational Company leader in Dublin
Dublin14.01.2020
Kellie O'Donovan's picture
Consultant | Engineering Recruitment - Quality & Validation
Cork 353 (0) 21 2300300 | kodonovan@morganmckinley.com