Quality Administrator

Who we are?  

Healthcare 21 is a sales, marketing, and technical services company. Our purpose is to deliver products and solutions to assist healthcare providers achieve optimum clinical outcomes.

We are high growth company that aims to be the partner of choice for our global healthcare suppliers; deliver on our promises to our customers across hospitals and the wider community; and promote ownership within our employees to be the best at everything they do​

We are a values-based company who recognise and reward employees that embrace our values of passion, innovation, transparency, and simplicity. At Healthcare 21, we are respectful of others and do not accept discrimination in any form. We believe it is our differences that are essential in forming our effective and creative teams and it has made us the sustainable business that we are today.

The long-term success of our sustainable business is based on our teamwork, integrity, and the ability of our people to take ownership of their role. It is our responsibility to provide you with an exciting, innovative environment that is respectful, fulfilling and rewarding. Want to know more about what to expect from a working life in Healthcare21, then click here.

Job snapshot

This role will be required to fulfil a full range of duties across the Healthcare 21 Group. You will be part of and support the quality and compliance team. You will oversee and manage the compliance program in collaboration with the Quality and Regulatory team. To develop, initiate, maintain, and revise policies and procedures for the general operation of the compliance program and its related activities to prevent illegal or improper conduct. You will have a strong drive for continuous improvement and a flexible approach to all areas of the role and work with multiple stakeholders across the Group, including Commercial, Customer Service, Warehouse and Management.

Candidate Location: Dublin

Responsibilities:

• Ensure that you comply with risk-assessed policies and procedures relating to IT Security, Health and Safety  

• Manage product complaints, maintain a product complaints log, and communicate details of complaints to the relevant departments and regulatory bodies.

• Support product recalls / notifications, maintain a product recall / notification control sheet and communicate details of Field Safety Notices to the relevant departments and regulatory bodies.

• Liaise with Senior Management, Commercial, Customer Service and Warehouse Managers in reviewing and improving processes, standards and delivery of specific projects as required.

• Assist in the successful completion of Quality audits, including supplier, ISO and HPRA

• Generation of KPIs, reports and minutes for Quality meetings.

• Ensure product compliance with EU legislation, MDR/IDVR, GDP & PV regulations, and requirements.

• Assist with organising and recording training regarding the quality system, applicable standards, and regulations across all departments.

• Perform any other ad-hoc duties as required by Management.

• Management and recording of AEs ADRs and PV issues, queries, regulations, and requirements.

• Support quality team with other role/requirements i.e., RP, AR roles

What are the role requirements?

• Capable of dealing with all complaints/issues in a professional. Efficient and confidential manner, ensuring that any non-compliance is immediately acted upon.

• Excellent time management skills with an ability to plan and prioritise workload.

• Ability to work effectively with all levels of the organisation and utilise a team approach to achieve goals and deliverables.

• Excellent attention to detail and accuracy.

• Ability to handle pressure and work to strict deadlines while maintaining a strong focus on process -orientated activities.

• Adaptable and ability to work on own initiative.

• Flexible approach to all areas of the role.

• Strong organisational skills with the ability to multi-task is a must.

Who exceeds in this role?

Top performers would have:

• Worked in an administrative role

• Working within a Quality Team experience an advantage

• Experience working as part of a project group / project management.

• High level of computer literacy including a good working knowledge of Microsoft Office

• Experience of working in a fast-paced, highly pressurised environment

• Experience in dealing with regulatory bodies would be an advantage.

• Experience working in a Medical Device company would be a distinct advantage.

• Experience working with Quality Management Systems, ISO and HPRA standards and regulations – ISO9001, ISO13485, ISO27001..

• Experience with Environment standards would be an advantage ISO14001.

What are some of the benefits of working at healthcare 21?

• Competitive salary

• Employee Assistance Program

• Pension & Life assurance

• Educational Assistance

• HC21 training academy

• Enhanced annual and life leave 

• Employee engagement initiatives and a dedicated internal employee communication platform WorkVivo

• Supportive colleagues to learn from and enjoy company social outings, parties, and events

We are proud to be an equal opportunity employer. At Healthcare 21 we know that diversity makes us stronger. We are committed to a collaborative, inclusive environment. We strive for everyone to feel valued, connected and empowered to reach their potential and contribute their best.

We also know the confidence gap can often get in the way of meeting spectacular candidates, so please don’t hesitate to apply — we’d love to hear from you!