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.
