JOM/AXXF-700335

Quality Systems Engineer

Location Kildare

Area Medical Device

The purpose of this role is to support the Quality Manager during a development 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.

Responsibilities:

• 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.
• Produce and maintain appropriate procedures to ensure compliance with regulatory requirements.
• Manage / execute site quality systems including CAPA, internal and supplier auditing and change control activities
• 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.
• Owner of batch release process in accordance with internal procedures.

• 3^rd 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. Strong problem-solving skills and ability to handle multiple tasks in a fast-paced environment.
• 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
• Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organisation.