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.
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