Senior Supplier Quality Engineer – Audits & CAPA

Cook Medical; Limerick; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Job summary

Cook Medical in Ireland (County Limerick) seeks a Supplier Quality Engineer to support supplier audits, process validation, CAPA and risk assessments from a quality perspective.

You will liaise with operations, engineering and quality control, drive supplier performance and continuous improvement while ensuring compliance with ISO, EU and FDA medical device standards. Travel may be required.

Qualifications

• Third Level qualification in Science, Engineering or a relevant technical discipline.
• Lead Auditor qualification preferable within Medical Device Industry.
• Knowledge of ISO, EU, FDA medical device standards.
• Statistics knowledge and data analysis ability.
• Strong communication and interpersonal skills.

Responsibilities

• Lead supplier quality audits and manage the supplier corrective action process.
• Monitor supplier non-conformance trends based on risk.
• Track supplier quality performance measurements and participate in evaluations.
• Drive continuous improvement in supplier quality and CAPA programs.
• Review supplier change notifications and supplier process validations.
• Coordinate with Quality Control for raw materials and QC issues.
• Support Internal, Supplier and Regulatory Audit Programmes.
• Carry out risk assessments of suppliers and materials.
• Ensure Cook's Code of Conduct is followed in business matters.

Job description

Cook Medical in Ireland (County Limerick) seeks a Supplier Quality Engineer to support supplier audits, process validation, CAPA and risk assessments from a quality perspective.

You will liaise with operations, engineering and quality control, drive supplier performance and continuous improvement while ensuring compliance with ISO, EU and FDA medical device standards. Travel may be required.