Uniphar Medtech Hiring For QMS Manager at Northern Cross, County Dublin Full Time

Reporting to the Director of Quality, Compliance and Regulatory Affairs, the Quality 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 14001 and sustainability standards.

Principal Duties & Responsibilities

Internal Audits to be scheduled and completed for the year for all sites and standards.

RP / Deputy RP activities to support the WDA.

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 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

Customer Satisfaction – manage the expectations of and requirements for a QMS for both internal and external stakeholders

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, ISO 14001, ISO 50001.

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.