Quality Operations Lead Location: Waterford About the Role My client is seeking an experienced Quality Operations Lead to play a key role in ensuring their quality systems and processes are robust, compliant, and consistently meet both internal and external requirements.
Key Responsibilities Quality & Compliance Ensure ongoing compliance with applicable standards including ISO 13485, FDA CFR 21 Part 820 (QMSR), and EU MDR.
Maintain audit readiness and lead/support external audits (Notified Bodies, customers, regulatory inspections).
Oversee Quality Operations processes, ensuring alignment with QMS and customer requirements.
Lead and support investigations (e.g.
non-conformances, complaints), ensuring timely closure and effective corrective actions.
Manage complaint handling and customer feedback processes.
Maintain and report on Quality metrics.
Drive continuous improvement initiatives across Quality and Compliance.
Support training systems and collaborate with HR on training metrics and reporting.
Leadership & Team Management Lead, mentor, and develop the Quality team, including Quality Release Inspectors.
Set clear objectives and performance targets aligned with business goals.
Conduct performance reviews, probation reviews, and return-to-work meetings.
Support recruitment and onboarding activities.
Manage team workload, scheduling, and holiday planning.
Promote a positive, high-performance team culture.
Cross-Functional Collaboration Work closely with Production, Engineering, Leadership, and Regulatory teams.
Support site-wide quality initiatives and ensure alignment across departments.
Act as a key stakeholder in operational and strategic quality decisions.
General Responsibilities Ensure compliance with Health & Safety standards and proactively address risks.
Maintain high standards of housekeeping and operational discipline.
Adhere to and support HR policies and procedures.
Collaborate with other departments and sites as required.
Skills & Experience Essential: 3+ years' experience in a quality role within a regulated environment.
Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
Experience in Quality Systems Management.
Proven experience leading and developing teams.