Overview
The Senior Quality Engineer will play a key role in driving compliance, supporting new product introductions (NPI), and maintaining the effectiveness of the Quality Management System (QMS). This position requires strong technical knowledge, leadership ability, and hands-on experience within the medical device sector.
Key Responsibilities
* Drive compliance and ensure achievement of organisational quality objectives.
* Support the implementation and continuous improvement of NPI processes and systems to enhance quality, efficiency, and product safety.
* Implement and maintain Lean Product Development practices.
* Develop and execute test strategies, methods, and validation protocols (including sterilisation, packaging, biocompatibility, and process validations).
* Support the Quality Management System, including management reviews, design control, change control, CAPA, risk management, and document control.
* Ensure the QMS remains compliant with ISO and FDA standards and other applicable regulations.
* Collaborate closely with project management teams and customers to successfully deliver projects that meet or exceed expectations.
* Mentor, develop, and support engineers and technicians, providing guidance, coordination, and feedback as needed.
* Support internal, supplier, customer, and regulatory audits, as well as certification activities.
Requirements
* Degree in a science, engineering, or technical discipline.
* Minimum of 5+ years’ experience within the medical device industry.
* Proven experience establishing and maintaining all aspects of a Quality Management System.
* Experience with cleanroom management, validation processes, and sterilisation validation is advantageous.
* Demonstrated ability to build, lead, and motivate cross-functional teams.
* Strong communication and stakeholder management skills, including experience engaging with senior leadership and customers.
* Experience in project environments and manufacturing product release processes is highly desirable.
* Agile, innovative, and proactive with strong problem-solving abilities.
* Experience with CAPA, risk management, document control systems, and NPI processes preferred.
Role Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Medical Equipment Manufacturing
Location: Galway, County Galway, Ireland
#J-18808-Ljbffr