Reporting to the Head of Quality and Compliance, the Quality Management Systems Manager will be responsible for leading and developing an integrated quality management system across our ten brands. Building on a strong well-established system in place currently, this role will build out our current QMS into a fully integrated system to include ISO 13485, ISO 9001, and relevant regulations.

You will be highly motivated, with a passion for Quality Management Systems and Quality Compliance and will support our continued drive towards excellence in service.

This is a great opportunity to work for a rapidly growing company and we are seeking someone who is eager to learn and thrive in a fast-paced environment.

This role will be based in our office in Northern Cross Business Park, Finglas, however you will be required to travel to other Medtech offices across IOI & the UK.

Key Duties and Responsibilities

This Job Profile is not an exhaustive list of duties for the position holder. It does, however, provide an indication of the main duties and responsibilities of the position.

Internal Audits to be scheduled and completed for the year for all sites and standards.
Ensure good communication with the site RP / DRP regarding site activities to ensure necessary RP oversight.
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 - covering all business units, 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 across several business units, to be developed out into Q-Pulse
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
Ensure validation and mapping schedules are maintained
Customer Satisfaction – manage the expectations of and requirements for a QMS for both internal and external stakeholders
Ensure customer complaints and recalls are managed by the team.
Preparation and facilitation for and involvement in external audits

Responsible for the introduction of new /amended SOPs into QMS working closely with the Projects Department,
Work to further develop the QMS across the Uniphar Medtech division into a consolidated QMS, in line with ISO 9001:2015, ISO 13485:2016, MDR, GDP.
Management of Quality Team members
Training creation and delivery for areas covered by the Quality Management System, including GDP and Regulatory requirements.
Co-Ordinate the activities necessary to ensure inspection readiness for all inspections and support the business unit to resolve any regulatory agency inspection findings.
Responsible for qualification and validation documents relating to premises and equipment

Role Requirements

The successful candidate will be hard-working and enthusiastic with a passion for Quality Compliance. They should have the following skills and qualifications:

Excellent communication and interpersonal skills
Third level qualification required in Quality, Science, or Business, or senior level experience
RP / deputy RP experience would be advantageous
Experience with Q-Pulse or other electronic Quality Management System is desirable
Minimum 5 years’ experience directly involved in a Quality Role within a well-developed QMS and a regulatory environment
Results / Output driven with the ability to drive a Quality agenda
Influence change across the organisation, sharing a vision for Quality
Good time management, planning and organisational skills
Keen attention to detail
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 as there is travel between our sites.
Travel across Ireland and occasional travel across European sites required

How we’d like to work together

This role will be based in our office in Northern Cross Business Park, Finglas, Dublin 11 where a flexible hybrid working model is also available. It’s important to achieve the right balance between face-to-face interactions with virtual working over the long term. In return for your flexibility, you will be joining an environment that understands how inter-twined work and life have become - and both the benefits and challenges that brings - and therefore offers a flexible, progressive way of supporting it.

Uniphar Medtech is an equal opportunities employer.

#unipharmedtech

QMS Manager

Job Description