Job Description

Supplier Quality Engineer - County Wexford

Ref No: AM18207

County Wexford, Republic of Ireland

Competitive salary

Supplier Quality Engineer - County Wexford.

In this role you will co-ordinate ongoing supplier monitoring activities. Lead Supplier Qualification and Supplier Component Qualification activities. Identify and escalate potential issues to management, while playing a key role in the resolution.

Main responsibilities will include:
• Management of supplier changes from receipt to assessment, validation, and approval
• Identify potential supplier risks to avoid any disruption to supply chain and report to senior management on all activities/actions taken.
• Assess the supplier management process effectiveness through internal audit and performance review.
• Monitor and measure supplier product and process quality.
• Identify process improvement opportunities using analytical framework.
• Apply creative problem-solving approach using statistical tools and techniques.
• Develop and maintain effective metrics for key activities.
• Perform risk management activities in a cross-functional environment.
• Ensure that documentation and work practices comply with ISO and regulatory requirements.
• Recommend corrections and improvements based on engineering studies/process/component validation and implement change.

Other task and duties may include:
• Perform internal and external auditing.
• Manage supplier audits, SCARs and improvement projects.
• Lead/participate in continuous improvement/CAPA team activities.
• Ensure regulatory compliance in area of responsibility to cGMP’s, with the ability to train others.
• Develop, maintain, and improve the quality management system.

Interested applicants should have:

• Bachelor’s degree, Engineering Degree, or degree in a technical field.
At least 4 years’ work experience in the medical device or pharmaceutical industry.
• Working knowledge of: Change control, Non-conformance, CAPA & statistical software (Minitab).
• Working knowledge of risk management documentation e.g. pfmea.
• Experience in the execution of all stages of equipment and process validation.
• Working knowledge of ISO 13485 and its applicability to the manufacturing environment.
• Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines.
• Problem solving ability with excellent organisational skills.
• Dedication to excellence, flexibility, attention to detail and adaptability to change.

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