IRecruit4 is representing a prestigious company in the Swindon area with a with a reputation for delivering high quality products and excellence in customer service. BENEFITS Salary- £40,000- £42,000 Monday to Friday, 9am - 5pm (37.5 hours per week) 33 days annual leave (inclusive of bank holidays) Modern, well-located office environment About you You will be self-motivated, able to start and finish tasks with minimal supervision You will be accurate and diligent in your work, comfortable working with detail You will relish the chance to manage multiple, often competing, priorities You will be a natural (written and oral) communicator with strong interpersonal skills You will thrive in a fast-paced environment and accept responsibility willingly You will be comfortable working proactively and independently to meet deadlines ABOUT THE ROLE We invite you to join a friendly and highly effective team at the forefront of the company. You will have a minimum of 2 years of experience in a Quality Engineer role. You will have a history of maintaining quality systems, working alongside fast paced production areas and implementing effective corrective actions alongside the production team. You will be a good communicator at all levels, particularly with your team and especially with your peers. You will be able to spot a problem and take the necessary steps to prevent unnecessary costs for the business. For the right person, this is an opportunity to learn from experienced professionals and launch your own career path within a business that is going places. RESPONSIBILITIES Support in the development, implementation, maintenance and control of on-going (or future) compliance to all certifications and standards relevant to the company. These will include as a minimum: ISO13485 (including EU MDR and UK MDR). Fully support the pack assembly team within the production environment and the custom pack team with set up of new packs as required. Aid and assist Third party manufacturing teams to work with Quality agreements and conduct site visits to ensure project completion and right first time quality is driven. Work with internal team members cross-functionally Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for New Product Development/Post Launch / lifecycle management activities. Act as product stewards for process FMEA and provides input on process validation to ensure manufacturing routes are capable of producing product to specifications. Collates and shares information/data through reports and follows up on identified improvement opportunities. Actively participates and/or drives Quality System improvements as required. Supports continuous improvement initiatives, process improvements to address operational issues using statistical process control (SPC) and Quality tools e.g. pareto, process capability, correlation analysis, etc. Performs internal and supplier audits as required. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate. Supports and process NC and/or Corrective and Preventive Action (CAPA) to address operational issues within the PPA areas. Supports with project related document and technical review. Generation and monitoring of data streams and analysis to support QMS maintenance and inform decision making across business. Work alongside internal customers to support in on-going compliance to internal QMS and external standard/regulation requirements. Provide ongoing support, training, facilitation, SME knowledge and tools across projects and departments. Responsible for maintaining a professional and harmonious working relationship with all colleagues, customers, clients, agents and third-party business partners or representatives of the Company Profile Experience within a highly regulated production environment Excellent analytical, communication and influencing skills. Excellent written, computing and verbal skills. Degree qualified (or with work-based equivalent experience) within a scientific or engineering discipline. Demonstrated ability to lead multiple projects and motivate cross functional teams whilst ensuring that deadlines are met. Competent auditor. Experience in hosting or acting as SME during external regulatory audits. Strong knowledge and experience of CAPA and NC for medical devices A practical working knowledge of implementation of change control, and of all aspects of the process and equipment validation lifecycle Desirable Requirements Knowledge and experience of PowerPoint and SAP and SPC systems Six Sigma green belt qualified and / or demonstrated ability in the use of quality engineering tools and techniques (quality core tools) and data interpretation. Experience in implementing/review of pFMEA. For further information please apply today