Quality Systems Controller
This role is key in assisting in the generation and maintaining existing quality systems and regulatory standards within all company facilities globally, reporting to the Global Quality Systems Manager. Establishing key performance indicators and metrics to successfully manage and improve performance is core to this role.
- Maintenance and supervision of internal document change order process for all company facilities (internal / contract).
- Ensure compliance with QMS procedures, protocols and systems.
- Assist and participate with Internal / External Audit system.
- Support in preparation and hosting of Third-Party Audits including audit training, control room setup, general audit readiness throughout the business and post audit follow up.
- Assist in the maintenance of / ensure compliance to the current / future quality systems in line with current regulatory requirements and industry best practices.
- Support system improvement initiatives throughout the company’s facilities.
- Develop / deliver key training programs to enhance quality and regulatory awareness in the company’s facilities.
- Advise on the requirements of post market surveillance to relevant QMS system.
- To assist in the maintenance of all records / files on all registrations of all existing company products worldwide. These include medical Device, food Supplement and cosmetic product registrations.
- To support all activities related to co-operation with all competent authorities and registration bodies as required with regard to medical Device, food Supplement and cosmetic product registrations.
- To assist in the research and development support on new and existing products and regions as required.
- To liaise with relevant regional offices and advise of registration status and any ongoing requirements.
- Compliance to all local site company policies, procedures and corporate policies.
- Perform additional duties at the request of the direct supervisor.
- Relevant third level qualification combined with 1-3 years of work demonstrated experience in the administration of related regulatory and / or quality Systems, or a combination of education and experience.
- A thorough working knowledge of quality systems such as ISO 9001, 13485, 21 CFR Part 820, EU 1223 and/or EU GMP is essential.
- Auditing experience to the requirements of ISO 9001 / 13485 / 21 CFR Part 820/EU GMP.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Must be able to work in a fast-paced environment.
- Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
- An ability to collaborate across functional lines and work effectively in a team environment.
- Must be able to work independently on own projects while working concurrently with all departments.
- PPE (safety shoes) are required to be worn at all time during working hours within Warehouse area.
For an immediate interview please forward your CV using the apply button
Or call Megan Warr on 091507515 for a confidential conversation