Come and join our Quality Operations Department as a Quality Engineer at our Royston site. We are looking for a Quality Engineer for the Quality Operations department at Sartorius. In this role, you will be responsible for ensuring compliance to ISO9001, managing the quality management system including internal audits. Additional audit activities will also include customer audits, managing deviations and CAPA activities.Contributing and driving improvement of quality processes. Key supporting task will require the supervision, development and coaching of QC resources to meet production demands for small scale equipment systems and consumable products. You will be joining a small team of quality professionals and will be integral to shaping the future site quality dynamic. This position is full time permanent role and site based at Royston, Hertfordshire. The operating site is 15 minutes' walk from the train station, just off of A505 with easy access. Grow with us - Your Responsibilities - On a daily basis you will be responsible for providing day to day quality support to production, support raising deviations, carry out investigations and support of the QMS - Drafting new and revising SOPs, writing investigations reports, support change control activities. - Maintain quality documentation including quality process maps, work instructions, testing protocols and testing evidence traceability and adhering to compliance - Driving continuous improvement to improve site product quality and customer experience including root cause analysis and solving customer complaints. - Raising CAPAS to ensure production quality and customer satisfaction - Manage internal and customer audits and ensure compliance for ISO9001 - Supervise QC resources to ensure smooth running of production operation - Collaborating and working directly with production engineering, product development and manufacture, supply chain and distribution teams. What will convince us - Bachelors degree in Science and Engineering or related field would be beneficial - Experience in a quality role in a manufacturing or production engineering environment in the pharmaceutical or medical industry ideally following ISO9001 regulation though candidates from other industries will also be considered ie.: automotive, aerospace etc. - Experience with ISO 13485 is advantageous - Strong analytical and troubleshooting skills - Experience of using Microsoft Office packages such as Word, Excel - Excellent written and verbal communication skills, with the ability to navigate challenging situations with internal and external stakeholders - Strong attention to detail - Strong organisational skills, to be able to juggle multiple processes and priorities In order to commence working with us, the successful candidate will have the right to work in the UK. What we offer As a growing global life science company, stock listed on the German DAX and TecDAX, Sartorius offers a wide range of benefits: - Personal and Professional Development: mentoring, leadership programs, internal seminar offerings - Making an impact right from the start: Comprehensive onboarding, including a virtual online platform - even before joining - Welcoming Culture: Mutual support, team-spirit and international collaboration; communities on numerous topics such as coaching, agile working and businesswomen network - Health & Well-Being: Wide section of health and well-being support such as healthcare plans and health assessment services Benefits Attractive Working Conditions: - 37.5 hours working week - 25 days annual leave, plus public holidays - Free parking on site - Annual option to buy, sell or carry forward annual year - Free hot and cold drinks - Regular social events and free exercise classes - Competitive benefits package, including: - Group Personal Pension Plan - Private Medical Insurance - Private Dental Insurance - Group Life Assurance - Group Income Protection - Cycle to work scheme About Sartorius Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers