We are a leading medical device company specialising in innovative, life-enhancing medical technologies and due to continue growth, we have an exciting opportunity for a Quality Specialist to join the team based in Crawley.
You will be responsible for the Quality Management System processes and procedures, including Information Governance requirements for the business.
You will act as the Quality Business Partner to multiple sites and related network. In conjunction with the Quality Manager you will be responsible for the development of the Quality Management support and contribute to the business and their strategy and programs.
In addition to this, you will be responsible for:
*Reviewing and establishing the company quality goals each year, in collaboration with the Quality Manager.
*Conduct internal audits and coordinate and manage external ISO audit schedules, correspondence and closing of findings.
*Manage and establish / maintain certification of ISO 90001 requirements across the business.
*Responsible for the Documentation Control Process and Documentation Change Control Process and act as the local document control tool point of contact.
*Implement Corporate and regional procedures and processes including Quality Management System reviews, as appropriate; implement and maintain processes required to support the business
*Ensure compliance with regulatory and quality requirements relating to service and repair for capital equipment placed on the market, in collaboration with Technical Services.
*Manage any local inspections & audits and ensure appropriate engagement with local, regional and business leadership.
*Liaise with internal and external customers as required, including local distributors, Agents and Non OEM Suppliers.
*Provide (quality) training to local staff as required, ensuring we remain in compliance with established quality and regulatory requirements.

Requirements:
*Knowledge and experience of implementing, maintaining and auditing to ISO 9001:2015 (2008 considered).
*Strong working knowledge of Quality Management System Requirements
*The ideal candidate will have good analytical skills; attention to detail and ability to manage multiple tasks and priorities at the same time.
*Experience within a manufacturing environment
*ISO 13485 knowledge beneficial

Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.

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