Quality Engineer 2, Supplier

emea-cookmedical; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

Cook Medical is seeking a Supplier Quality Engineer to lead supplier quality audits, monitor non-conformance trends, and drive continuous improvement in supplier quality.

You will collaborate with Quality, Engineering, and Purchasing to ensure compliance with ISO/EU/FDA standards and support CAPA and change management processes.

Qualifications

• Third Level qualification in Science, Engineering or a relevant technical discipline.
• Qualified Lead Auditor (desirable in Medical Device industry).
• Quality/Validation/Statistics qualifications are advantageous.
• Knowledge of ISO, EU and FDA medical device standards is required.
• Experience in Validation including Process and Design Validation.
• Proven statistics knowledge.

Responsibilities

• Lead supplier quality audits and manage supplier corrective action process.
• Monitor supplier non-conformance trends based on risk.
• Track supplier quality KPIs and participate in supplier reviews.
• Drive continuous improvement in supplier quality.
• Review and support supplier change notifications and validations.
• Maintain supplier quality documentation with purchasing.
• Provide QA support to QC and testing activities.
• Support CAPA and non-conforming product processes.
• Assist internal/audit programmes and risk assessments.
• Prioritise quality issues and ensure timely action.

Skills

Auditing

Quality systems

Statistics

Interpersonal skills

Problem solving

Attention to detail

Organisational skills

Self-motivation

Travel readiness

MS Office

Education

Science/Engineering degree

Tools

Microsoft Office

Job description

Overview

The primary function of this role is to provide Supplier Quality Engineering support to the monitoring, approval and appraisal of suppliers from a quality perspective. Provide support and guidance to departments liaising with suppliers from an operations, engineering and quality control perspective. This includes, but is not limited to, providing support to supplier audits, process/ supplier validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, risk assessment and associated Quality System Documentation.

Reporting to: Team Lead, Quality Engineering

Department: Supplier Quality Engineering

Find out more about Cook Medical here

Responsibilities

• Department: Supplier Quality Engineering
• Lead supplier quality audits and management of the supplier corrective action process. Maintain and update supplier audit schedule when required.
• Implement and develop mechanisms to monitor and identify supplier non-conformance trends based on risk.
• Track supplier quality performance measurements for suppliers (KPI’s) and participate in supplier performance reviews. Completion and approval of supplier evaluations and monitoring when required.
• Manage and drive continuous improvement activities focusing on supplier quality.
• Review and support Supplier Change Notifications.
• Review and approval of raw materials, first part approval and supplier process validations.
• Maintaining supplier quality documentation in conjunction with purchasing.
• Liaise with Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control for raw material issues.
• Provide input and support to the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
• Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes.
• Completion of risk assessment of suppliers, non-conforming materials and CAPA’s.
• Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
• Designee to the Senior Quality Engineer/ Quality Engineering Team Lead.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

• Third Level qualification in Science, Engineering or a relevant technical discipline.
• Qualified Lead Auditor, preferably within the Medical Device Industry desirable.
• Qualification in Quality/Validation/Statistics would be a distinct advantage.
• Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
• Proven knowledge and experience of all aspects of Validation including Process Validation and design validation.
• Good working knowledge of statistics.
• Strong interpersonal skill with the ability to communicate effectively at all organisational levels.
• The ability to challenge thinking/opinion/actions in light of ensuring Cook Medical Quality Systems and Processes are adhered to.
• High attention to detail in all aspects of the role.
• Excellent organisational skills.
• Proven problem-solving skills.
• High self-motivation.
• Good working knowledge of Microsoft Office.
• Willingness and availability to travel on company business.