What you need to know
You will work as a Senior Quality Systems Engineer for our client, a highly successful manufacturing company based in Kildare.
This is a permanent role.
As the Quality Engineer, you will assist the Senior Quality Systems Engineer in the implementation of the company Quality Management System.
- Own and manage the various components of the MGS quality management system
- Manage the internal audit program and supplier audit program.
- Lead auditee for Regulatory, Customer and Corporate audits
- Complaint trending and monitoring of corrective actions in order to drive continuous improvements.
- Maintenance & communication of GMP standards throughout the plant.
- Development, issuance and implementation of QA documentation.
- Produce and maintain appropriate and procedures to ensure compliance with regulatory requirements
- Complete management review and close out on any actions identified.
- Compile and execute validation protocols for the manufacturing processes and equipment of existing and new products. Ensure correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
- Manage / execute site quality systems including CAPA, internal and supplier auditing and change control activities.
- Knowledge and adherence to regulatory standards including ISO 9001, ISO 13485.
- Delivering in-house training on quality assurance documents, concepts and tools.
- Owner of batch release process in accordance with internal procedures.
- Review and approval of site change control documents
- Generate and monitor site quality KPIs
- Ad hoc activities as required.
What are we looking for
- 3rd level Qualification in Quality / Science / Engineering with a minimum of 5 years work experience in a Quality Engineering role.
- Experience working with an ISO13485:2016 compliant quality system essential.
- Lean/Six Sigma Training advantageous
- Self-directed and results driven team player. Ability to work on own initiative, to deadlines, while also capable of working as part of a multi discipline team
- Strong problem solving skills and ability to handle multiple tasks in a fast paced environment.
- Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organisation.
- Excellent organisational skills, ability to take on and drive a project.
Apply for this job now or get in touch with Joanne on 01 4690901.
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