Job Title: Senior Quality Engineer (Supplier)

Location: Limerick, Ireland

Overview:

The primary function of this role is to provide technical leadership within Supplier Quality Engineering and support the monitoring, approval, and appraisal of suppliers from a quality perspective. The role provides guidance to departments liaising with suppliers across operations, engineering, and quality control. Responsibilities include support for process/supplier validation, change requests, non-conforming product issues, corrective and preventive actions (CAPAs), risk assessments, and associated Quality System documentation.

Reporting To: Team Lead, Quality Engineering

Department: Supplier Quality Engineering

Key Responsibilities:

• Drive all assigned Supplier Quality Engineering projects, ensuring structured management and completion in compliance with procedures.

• Manage project activities to ensure timely completion of milestones.

• Represent the team at key review meetings.

• Build effective relationships with cross-functional teams, including Operations, IT, Engineering, and Regulatory.

• Lead compliance initiatives in line with FDA, QSR, and ISO 13485 requirements, promoting best industry practices.

• Identify and implement process and quality improvements proactively.

• Ensure in-house and supplier quality issues are prioritized and resolved in a timely manner.

• Perform supplier quality audits and manage the supplier corrective action process; maintain and update supplier audit schedules as required.

• Monitor supplier performance, track KPIs, and participate in supplier performance reviews.

• Support supplier change notifications and approval of raw materials, first part approval, and supplier process validations.

• Maintain supplier quality documentation in collaboration with purchasing.

• Provide Quality Engineering support to Incoming, In-Process, and Final Quality Control for raw material issues.

• Support CAPA and Non-Conforming Product processes.

• Assist with internal, supplier, and regulatory audit programs.

• Conduct risk assessments of suppliers, non-conforming materials, and CAPAs.

• Act as a designee to the Quality Engineering Team Lead when required.

• Ensure ethical conduct and compliance with organizational quality policies in all supplier interactions.

Qualifications & Experience:

• Third-level qualification in Science, Engineering, or a relevant technical discipline.

• Additional qualification in Quality, Validation, or Statistics is advantageous.

• Knowledge of ISO, EU, and FDA medical device standards and regulations is required.

• Qualified Lead Auditor certification is desirable, preferably within the medical device industry.

• Proven experience in all aspects of validation, including process and design validation.

• Good working knowledge of statistics.

• Strong interpersonal and communication skills across all organizational levels.

• Ability to challenge decisions to ensure adherence to quality systems and processes.

• High attention to detail and excellent organizational skills.

• Strong problem-solving skills and self-motivation.

• Proficient in Microsoft Office.

• Willingness and availability to travel as required.