Quality and Compliance Specialist

Role Title: Quality and Compliance Specialist

Location: Ballina, Co. Tipperary

Role Type: Permanent

We are seeking a Quality and Compliance Specialist to join a leading provider of specialist equipment, products, consumables, and services. In this role, you will support the Quality and Regulatory Affairs Manager while gaining valuable exposure to a broad range of quality assurance activities. This is an excellent opportunity for someone looking to advance their career in quality assurance and contribute to meaningful work in a dynamic, fast-paced environment.

Main Duties and Responsibilities

In this role, you will:

• Foster a commercially orientated, quality-driven culture.
• Manage, operate, and further develop integrated systems.
• Ensure compliance with ISO 9001, ISO 13485, ISO 17025, and ISO 27001, and assist implementation of any new ISO standards.
• Support the achievement of company quality performance objectives.
• Oversee the CAPA, internal audit, and risk management processes.
• Partner with managers and staff to address non-conformances and enhance procedures.
• Develop and deliver quality-focused training programs, including staff induction and ongoing training.
• Manage quality actions with customers and suppliers, including customer complaints, product recalls and adverse events and general queries.
• Oversee supplier and product onboarding, ensuring market accessibility in line with the requirements of MDR/IVDR and other applicable EU regulations.
• Liaise with external regulatory bodies such as the NSAI, INAB, and HPRA on all quality and regulatory matters.
• Monitor regulatory changes and ensure ongoing compliance.
• Oversee the operation and maintenance of the calibration laboratory, ensuring accurate performance and acting as the final approver for all accredited calibration certificate
• Implement and maintain strong Information Security practices, including safeguarding data, following company policies, and reporting risks or inappropriate use.
• Promote and protect workplace Health & Safety, in line with the company’s Safety Statement and Risk Assessments.
• Participate in management review meetings and contribute to decision-making.
• Adhere to all company SOPs and take on additional tasks as assigned

What We’re Looking For

You’ll thrive in this role if you are:

• Detail-oriented, with a passion for quality and continuous improvement.
• Collaborative and approachable, with strong relationship-building skills.
• Confident in working with standards, audits, and regulatory bodies.
• Keen to grow your career in quality and compliance within a respected and supportive organization.

Required Qualifications/Experience:

• Degree in Science/Engineering or QQI is desirable.
• Minimum 2-5 years’ industry experience in a similar role.
• Preferred Experience (but all not essential): ISO 9001, ISO 13485, ISO 17025, ISO 27001, MDD / MDR, IVDD / IVDR.