I am recruiting for a Quality System Engineer - Injection Moulding Manufacturing position for my client. They are a multinational company specialising in tooling, moulding and automation technology. They manufacture and provide high spec products and solutions for industry leaders within the pharmaceutical / medical device, healthcare, automotive and consumer product industries.
Location: Leinster, Ireland.
Package: Full time, permanent position, Mon - Fri 8am - 4pm (3pm on a Friday) might be open to some flexibility. There is an excellent salary on offer including benefits, health, pension. Contact Enya Mc'Brierty in ManpowerGroup Ireland.
The purpose of this role is to support the Quality Manager in an expansionary phase of this high-volume manufacturing plant. The role will involve liaising across the organisation to ensure internal system compliance and customer specifications are achieved. It will also demand the timely and effective closure of internal/external quality issues in a culture of compliance and continuous improvement
Primary Responsibilities for role:
- 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
Your knowledge and experience:
- 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
If you are interested in this Quality Systems Engineer - Injection Moulding Manufacturing's position please contact me through LinkedIn or directly to arrange a confidential follow up call.