Quality Systems and Compliance Manager
Quality Systems and Compliance Manager
Our client a medical device company is recruiting for a Quality Systems and Compliance Manager for their site in Galway. This is a permanent role and is commutable from Clare and Mayo.
The role is a key role within the global QA organisation and responsible for the overall effectiveness of the quality system deployed across the Manufacturing and Commercial sites.
The Quality Systems and Compliance Manager will work across the quality system lifecycle from design through post market surveillance, collaborating with partners in all functions including R&D/Design Assurance/Supply Chain/Clinical/Marketing/Regulatory/Commercial, to ensure roles & responsibilities and accountabilities are clear in the implementation of a best in class quality system.
- Establish, implement, and maintain the Quality Management System, providing direction and support to all functions, manufacturing sites, and commercial entities, in areas of design quality, production and process controls, distribution quality, post market activities.
- Keep the Leadership up to date on all changes to the quality system and provide updates of any system gaps that require resolution together with plan to remediate.
- Lead and co-ordinate the QMS Integration project across both manufacturing and commercial sites, working with the Site project leads to ensure project plans are in place and tracking to milestone targets.
- Lead and co-ordinate other strategic quality projects such as the deployment of automated quality systems at sites, collaborating in partnership with divisional and IT leads to ensure requirements/expectations are aligned for effective deployment of these quality system processes.
- Represent quality and take an active role in participating on Project Steering teams to ensure that project oversight and governance is in place and effective.
- Develop strong communications with both the divisional Quality Systems lead and the quality systems group. Collaborate closely with both groups to ensure internal requirements are understood and consistently deployed across a number of sites as well as co-ordinating the annual audits at those sites.
- Work with the certain sites and QA leads (manufacturing & commercial) to plan, prepare, and manage all quality system audits both internal as well as external Regulatory inspections.
- Drive improvements and standardisation in all of the key quality system areas (Management Review/CAPA/Complaints/Design Controls/Audit/Validation/Environmental controls) across all sites through a Community of Practice approach and close linkage within the quality groups.
- Develop the knowledge and understanding of all staff regarding quality system requirements and provide the appropriate training to functional experts who are accountable for the delivery of quality system requirements.
- Collaborate effectively with cross-functional colleagues to ensure that the quality system meets the company’s Policies and Standards as well as all external regulatory requirements.
- Develop and maintain a strong Management Review process that consistently reports to BU Site Leadership on the effectiveness of the quality system, and ensures that we are meeting our audit commitments and external regulatory bodies.
- Work closely with the RA team to understand changes in regulatory requirements that may impact the quality system, and develop effective communications with key regulatory agencies such as World Health Organisation, Notified Bodies, NMPA, FDA, and all other applicable authorities.
- Bachelor of Science/Engineering or related discipline
- Minimum 10 years work experience, including at least 5 years in a regulated environment (IVD/Medical
- Devices/Pharma), with minimum of 3 years in a Quality management role.
- Strong understanding and experience in the implementation of ISO 13485, ISO 14971, IVDR/MDR
- quality system requirements, FDA QSR’s, as well as key global regulations – GA/PMDA/NMPA/WHO
- Strong communication skills and ability to influence peers and Senior Management
- Collaborate effectively across functions and deliver results through people engagement
- Develop staff in quality system requirements and ensure strong capability/competence levels
- Ability to build an effective quality system, and efficient processes that support BU/Site business objectives
For further information on this Quality Manager role in Galway please contact Helga Reeves on 086 8168298 firstname.lastname@example.org
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