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My client which is an International Medical Device Distributor with operations in Ireland, UK, EU, and US has a need for a Quality Manager.
Reporting directly to the Director of Quality, Compliance and Regulatory Affairs you will work with international subsidiaries ensuring that robust Quality Management Systems are putting in place for all local, national, and international standards and regulations.
With two direct reports and multiple stakeholders both internally and externally you will work on a range of Projects to maintaining existing processes as well as developing new systems in line with international best practice.
I am keen to talk with; hands-on and self-confident managers, who have a track record of leading and mentoring team members to deliver best in class standards within the industry.
You will need to come from the Medical Device / Pharmaceutical industry, and have a detailed knowledge of relevant, ISO, MDR and Quality Management Systems – APPLY TODAY
Quality Manager / QMS / ISO 9001:2015 / ISO 13485:2016 / MDR / GDP / ISO 14001 / ISO 50001 / Leadership / Q-Pulse / Dublin / Ireland
Job Title: QMS Manager
Main Office: Dublin
Travel: 10% – 15%
Direct Reports: (2)
- Full Time / Perm Role
- €65k – €75k+ (Basic) Negotiable
- Annual Bonus (10%)
- Health Insurance
- Pension (5%)
- Paid Annual Leave
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 10 Medical Device Distributors based in Ireland, UK & Mainland Europe. 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.
- 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 divisions into a consolidated QMS, in line with ISO 9001:2015, ISO 13485:2016, MDR, GDP, ISO 14001, ISO 50001.
- Management of Quality Team members (2)
- 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
- 3rd Level Qualification in Quality/Science/Business
- 5-8 Years working in a Quality Management role within Medical Device / Pharma
- RP / deputy RP experience would be advantageous
- Experience with a QMS software solution. QPulse experience would be advantageous.
- A strong understanding of the MDR Regulations, ISO, Good Distribution Practice
If you would like to be considered for this opportunity why not contact me directly on my mobile 00353 (0) 87 25 35 247, Just ask for Patrick.
Alternatively, follow the links below and send me your CV.
Key Words: Quality Manager / QMS / ISO 9001:2015 / ISO 13485:2016 / MDR / GDP / ISO 14001 / ISO 50001 / Leadership / Q-Pulse / Dublin / Ireland
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