Quality Engineer 2, Supplier

Cook Group

. Provide Quality Engineering support to monitoring, approval and appraisal of suppliers from a quality perspective .

Posted 9/15/2026full-timeLimerick • IrelandMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Engineering, focusing on supplier quality management, validation processes, and compliance with ISO, EU, and FDA medical device standards. Proven ability to conduct audits, manage corrective actions, and drive continuous improvement initiatives.

Highest-signal resume keywords

Supplier Quality AuditsProcess ValidationCAPA ManagementISO, EU, FDA RegulationsLead Auditor Qualification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality EngineeringValidationRisk AssessmentSupplier Performance TrackingNon-Conforming Product ManagementQuality System DocumentationStatistical AnalysisSupplier EvaluationContinuous ImprovementQuality Control

Soft Skills

Interpersonal SkillsEffective CommunicationAttention to DetailOrganizational SkillsProblem-Solving

Tools & Technologies

Microsoft Office

Certifications & Qualifications

Third Level Qualification in Science or EngineeringQualification in Quality/Validation/StatisticsLead Auditor Certification

Industry Keywords

Medical Device StandardsSupplier Quality ManagementInternal AuditVendor AuditRegulatory Audit

About the role

Key responsibilities & impact

Provide Quality Engineering support to monitoring, approval and appraisal of suppliers from a quality perspective
Provide support and guidance to departments liaising with suppliers from operations, engineering and quality control perspectives
Support process and supplier validation, change requests, non-conforming product issues, CAPA, risk assessment and Quality System Documentation
Perform supplier quality audits and manage the supplier corrective action process
Maintain and update the supplier audit schedule
Develop mechanisms to monitor and identify supplier non-conformance trends based on risk
Track supplier quality KPIs and participate in supplier performance reviews
Complete and approve supplier evaluations and monitoring
Manage and drive continuous improvement activities focused on supplier quality
Review and support Supplier Change Notifications
Review and approve raw materials, first part approval and supplier process validations
Maintain supplier quality documentation with purchasing
Provide Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control for raw material issues
Support the Cook Medical CAPA and Non-Conforming Product Process
Support Internal Audit, Vendor Audit and Regulatory Audit Programmes
Complete risk assessments of suppliers, non-conforming materials and CAPAs
Provide quality measurements and ensure quality issues are prioritised and acted upon promptly
Act as designee to the Senior Quality Engineer/Quality Engineering Team Lead
Ensure Cook’s Code of Conduct is considered in business matters

Requirements

What you’ll need

Third Level qualification in Science, Engineering or a relevant technical discipline
Qualification in Quality/Validation/Statistics would be a distinct advantage
Knowledge of relevant ISO, EU, FDA medical device standards regulations is required
Qualified Lead Auditor, preferably within the Medical Device Industry desirable
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
Ability to challenge thinking/opinion/actions to ensure Cook Medical Quality Systems and Processes are adhered to
High attention to detail
Excellent organisational skills
Proven problem-solving skills
High self-motivation
Good working knowledge of Microsoft Office
Willingness and availability to travel on company business

Benefits

Comp & perks

Equal opportunity employer committed to treating employees equally regardless of gender, civil status, family status, sexual orientation, religious belief, age, disability, race or membership of the traveller community
Workplace and recruitment accommodations to facilitate participation and ensure equity