Our client is a the leading medical device distributor across Ireland and the U.K. They are seeking a QMS Specialist with a minimum of 1 years previous experience. The QMS Specialist will report to the QCRA Manager across the Healthcare Group to support their Quality Management System requirements. This role will require occasional travel between offices in Dublin, Belfast and Great Britain. A full, clean drivers licence is required. This role requires a person who is capable of developing strong internal customer relationships between their various sites.
• The primary purpose of the role is to be responsible for the management of our clients QMS requirements ensuring our client meets and exceeds their contractual and regulatory obligations, providing best practice in QMS.
• Our clients Quality Management System needs to fulfil the requirements of a QMS for ISO 9001:2015, Wholesale Distributors Authorisation (WDA) from the HPRA, GDP requirements for EUDR for Medical Device Distribution as well as LSAS (Labour Standards).
• Internal Audits to be scheduled and completed for the year for all sites and standards.
• CAPA including Root Cause Analysis- review and follow up of actions and their effectiveness
• Annual checks to be completed –all records required to be documented
• Management review - by business unit, and by standard
• Monthly / quarterly updates and all documentation to be filed
• Document Control Schedule - SOPs / Policies / Flows / Forms - register and management of same including version control for SOPs, index register, go live and communication.
• Change Control – management of Change Control Process, document each request and follow up for close out
• Risk assessment and mitigation actions documented and followed up with relevant Managers
• Monthly / quarterly metrics to report on progress on each functional area
• Quarterly Feedback review metrics, by business unit– documents actions and close out
• Ensure records are maintained of Temperature and Humidity monitoring requirements
• Customer Satisfaction – manage the expectations of and requirements for a QMS for both internal and external stakeholders
• Preparation for and involvement in external audits
• Responsible for the introduction of new /amended SOPs into QMS working closely with the Projects Department
The successful candidate will be hard working and enthusiastic with an interest in Quality Compliance, possibly pursuing further training in this area.
They should have the following skills and qualifications:
• Third level qualification required in Quality, Science, or Business
• Minimum 1+ years’ experience (or studying in this area) directly involved in a Quality Role within a well-developed QMS and a regulatory environment
• Experience of working according to the following standards: ISO 9001:2015, Wholesale Distributors Authorisation (WDA) from the HPRA, GDP requirements for EUDR for Medical Device Distribution as well as LSAS (Labour Standards).
• Strong communication, interpersonal and prioritising skills
• Results / Output driven with the ability to drive a Quality agenda
• Influence change across the organisation, sharing a vision for Quality
• Good time management
• Keen attention to detail
• Good planning & organising skills
• Ability to work effectively and co-operatively with others – stakeholder management
• A good work ethic with a positive, can do attitude and approach to work
• Ability to work on their own initiative and equally as part of a team
• Full Clean Driving License required
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256