Contract Quality Engineer

Job Title: Contract Quality Engineer - Medical Devices

Location: Ireland

Type: Contract, 6 Months

Onsite 5 days a week

About Us:

We are currently supporting in a search seeking a highly skilled Contract Quality Engineer. This individual will play a key role in ensuring compliance with ISO 13485 standards, managing CAPA processes, and driving continuous improvement initiatives.

Job Overview:

As a Contract Quality Engineer, you will be responsible for overseeing the quality and compliance aspects of their medical device manufacturing processes. Working on-site five days a week, you will collaborate with cross-functional teams to implement and maintain quality systems, specifically focusing on Corrective and Preventive Action (CAPA) processes. Your expertise in ISO 13485 will contribute to maintaining regulatory compliance and enhancing the overall quality of their products.

Key Responsibilities:

CAPA Management:

• Lead and manage Corrective and Preventive Action (CAPA) processes to address deviations, non-conformities, and customer feedback.
• Conduct thorough investigations, root cause analyses, and implement effective CAPA solutions.

ISO 13485 Compliance:

• Ensure compliance with ISO 13485 standards throughout the product lifecycle.
• Support internal and external audits related to ISO 13485 and other relevant regulations.

Quality System Implementation:

• Implement, maintain, and enhance quality management systems to meet regulatory requirements and industry standards.
• Collaborate with cross-functional teams to ensure adherence to quality processes.

Risk Management:

• Apply risk management principles to identify and mitigate potential quality issues.
• Collaborate with teams to integrate risk management into product development and manufacturing processes.

Continuous Improvement:

• Analyse quality data, trends, and metrics to identify opportunities for process improvements.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.

Qualifications:

• Years of experience in Quality Engineering within the medical device industry.
• Strong knowledge of ISO 13485 standards and experience in implementing and maintaining quality management systems.
• Proven experience in managing CAPA processes.
• Familiarity with regulatory requirements for medical devices.
• Excellent communication and collaboration skills.
• Ability to work effectively in a cross-functional team environment.