Join one of Irelands most successful Medical Device companies as a Senior Quality Engineer.
The Senior Quality Engineer (SQE) will play a key leadership role within the Quality Assurance team, providing oversight, technical expertise, and mentorship to junior engineers. Acting as the go-to person for quality matters, the SQE will ensure compliance with regulatory requirements, lead problem-solving for manufacturing and supplier issues, and drive continuous improvement initiatives.
Key Responsibilities
Leadership & Mentorship
* Provide guidance and oversight to junior Quality Engineers.
* Review and approve work carried out by other engineers.
* Act as a strong voice and decision-maker within the team.
Manufacturing Support
* Lead responses to manufacturing issues and quality queries.
* Drive continuous improvement projects across manufacturing processes.
* Support production teams by implementing corrective and preventive actions.
Audit & Compliance
* Lead preparation and coordination for external audits (e.g., BSI, notified bodies).
* Chair the monthly
Material Review Board (MRB)
meetings, ensuring cross-functional alignment and follow-up actions.
* Support change assessments for manufacturing equipment and processes.
Supplier Quality
* Manage relationships with external suppliers and support resolution of supplier issues.
* Lead supplier audits (occasional travel required, approx. once per year).
* Ensure supplier changes are properly assessed and documented.
Qualifications & Experience
* Minimum 3 years' experience in Quality Engineering (5+ preferred).
* Strong knowledge of quality systems in a medical device manufacturing environment.
* Experience preparing for and leading external audits.
* Proven ability to lead cross-functional meetings and projects.
* Experience in supplier management and audits (auditor qualification a plus; training provided if not already certified).
* Excellent communication skills, with confidence to influence and guide colleagues.
* A proactive, self-starting mindset with strong problem-solving ability.
Excellent starting salary, 10% bonus, comprehensive family health insurance, generous bonus & share options available.