Overview
Join one of Ireland's 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.
Responsibilities
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; 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.
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