QMS Engineer

Quality Management System (QMS) EngineerLocation: Oxford (4 days on site, 1 day work from home)About the jobWe are working with an Oxford-based start-up, who are pioneering the development of analytical instruments for scientists. Their unique products provide vital insights for scientific discovery, R&D and therapeutics production. More than 350 instruments have now been installed in labs around the world. Spun out of Oxford University in 2018, the company have quickly scaled to be an international player with offices in in the US, Asia and it’s headquarters in Oxford, UK.This is an exciting opportunity for an experienced QMS Engineer to join the Quality Team. Reporting directly to the Quality Director, you will play a pivotal role in selecting and implementing an eQMS system to help drive the organization towards ISO9001:2015 certification (projected in 2025).You will also participate in an internal inspection readiness program, providing support for the rest of the organization and collaborating with internal departments to ensure any quality processes are implemented effectively.This role would suit a driven individual with a proven track record of successful eQMS implementation as well as SME, who can provide technical knowledge and expertise.If you like to work in a fast-paced, driven environment, we’d like to hear from you!Key Responsibilities:Lead the development and implementation of an eQMS system to achieve ISO9001:2015 certification in 2025.Manage the migration of current documented processes into the eQMS.Coordinate all activities within the eQMS system from early stages through to full implementation across all sites within the company.Oversee the training and roll-out plan of ISO9001:2015 across the business.Support Subject Matter Experts across the business in creating new ISO9001:2015 compliant processes and documentation.Assist the Quality Director with hands-on supervision of the project, ensuring it meets agreed time, cost, and quality deliverables and aligns with the delivery strategy.Serve as the eQMS Subject Matter Expert, leading system administration and driving improvements and developments as required.Lead the implementation efforts with SMEs across the business through regular review meetings, action plans, and, when necessary, escalate risks/delays to the Quality Director.Ensure the system is operational for all sites 24/7, maintaining critical functionality.Develop implementation plans and training for new eQMS elements.Provide ISO9001:2015 and eQMS training for new employees.Requirements:Advanced experience in ISO: 9001:2015 Quality Management Systems (ISO13485:2016 also considered).Basic project management or leadership experience in implementing new systems (or equivalent skills).Understanding of 'Best Practice' and the ability to apply 'out of the box' solutions for the business.Be a role model for Quality across the organization by doing things right and doing the right things.Comply with policies and procedures and fulfill roles and responsibilities as defined to support full compliance.Communicate effectively both in writing and verbally.Complete work according to agreed priorities and due dates, reporting to those in authority if any timelines are likely to be missed.Experience in Biotech/MedTech is desirable but not essential.Please apply with an up to date CV for consideration.