Quality Manager

Job Description

Quality ManagerEdinburghPermanent£60,000 - £70,000Kelly Scientific are delighted to be partnered with a dynamic, rapidly expanding human cell culture specialist developing new innovate products and solutions for the fields of drug discovery & toxicology to recruit a Quality Control Scientist to join the teamin Edinburgh on a permanent basis. Based at their state-of-the-art facilities in Edinburgh, we are seeking an experienced Quality Manager to be a passionate and inspirational leader, you will be accountable and responsible for the day to day running and continual development of the quality team,systems, processes and procedures and be focused on end-to-end ownership of company quality activities Reporting to the Site Lead, with a proven track record as a successful Quality Manager within a Life Sciences environment, you will be autonomously responsible for driving a true Quality Assurance culture across the business. Key Responsibilities * Leading all site-wide quality activities and ensuring product quality meets company, industry and regulatory requirements * Engendering a quality culture across all operational activities * Lead, mentor and develop the site engineering and scientific quality team * Development and roll-out of company quality strategy, systems and procedures to ensure continuous process improvement and dissemination of good practice * Ensure organisations product lifecycle activities meet global market regulatory requirements * Maintain the current Quality system, ISO 9001, and lead in delivering the QMS infrastructure to achieve ISO13485 certification * Ensure that product change and design control processes are followed throughout the cycle of R&D, technical transfer, manufacturing and post-market release * Monitoring and analysis of quality KPIs, deviations, non-conforming product, complaints, change management and CAPA processes to identify trends through statistical analysis * Lead the organisations quality risk management and mitigation strategy * Lead introduction of "Q Pulse" electronic quality management system * Travel to and provide support for other sites leadership and Quality Assurance team as required Essential skills * This key leadership position is accountable for improving product and process quality and particularly suited to a Quality Manager with a proven track record of embedding change and encouraging continuous improvement * You will be an inspirational, collaborative leader who will be able to demonstrate previous experience in leading and managing all elements of the company quality function within a Life Sciences environment - previous experience within a cell culture developmentenvironment a distinct advantage * A natural problem solver that can identify short term mitigation and propose options for longer term resolution * You will have implemented and developed an ISO Quality system, ideally ISO13485, and led and managed all external audits and regulatory agency inspections * You will mentor and provide guidance to all internal and external stakeholders on implementing and maintaining product compliance and drive best practice processes * You will possess excellent judgement and solid decision-making skills with an inherent ability to work under deadline pressures If you are interested in this position, please apply or contact the Kelly Scientific team on for more information.Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kellys Privacy Statement. For information regarding data protection at Kelly, please visit theKelly website and have a look into the Privacy Statement.As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.