Your new company
A market leader and fast-moving, quality-driven manufacturer in the heart of Mid Ulster. They design, manufacture and distribute globally and have great plans for the future. Joining this team at this point will be a great opportunity as they are expanding and experiencing growth.
Your new role
Provide Quality and Regulatory strategic direction, training, and support to the organisation. Responsible for ensuring business activities are conducted in compliance with medical device regulations and standards applicable to our business and product range. Ensure product lifecycle activities meet the Quality and Regulatory requirements of applicable global markets. Represent and monitor the quality management and the quality view in projects, production, and product risk. Develop the quality management system to meet all applicable ISO13485:2016, customer and regulatory requirements. Manage certifications/recertifications including country-specific product registrations. Ensure the continuous improvement of products and processes and lead internal and external audits.
What you'll need to succeed
You will have experience as a Quality Manager within a highly regulated environment. Expertise in quality system standards and regulations, preferably including ISO13485. Demonstrated ability and expertise in leading quality assurance and regulatory teams as related to medical device design, production, and distribution. Strong leadership, communication, technical writing, and interpersonal skills, with demonstrated ability to mentor, train, and develop direct and indirect team members. Strong analytical and problem-solving skills, along with data analysis and implementing improvements.
What you'll get in return
You will receive a competitive salary, pension contributions and have the opportunity to join an extremely successful business.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Experience: 0 yrs