MP Recruitment Group Chesterton, Oxfordshire
A Quality Assurance Officer to support the Quality Manager to ensure compliance with ISO13485:2016 medical device quality standards and other applicable regulatory standards and customer requirements. The Company is expanding and needs someone to support the Quality Manager on a range of client and inhouse projects, including document control and laboratory compliance checks. The successful candidate will be provided with training and ample opportunity to take on additional responsibility and advance their career. Main responsibilities Document Control: Assist the Quality Manager with the maintenance of the ISO 13485 Quality Management System (QMS). Create, revise and control documents including standard operating procedures, work instructions, forms, templates and equipment records. This will involve close collaboration with people in manufacturing, R&D, and the facility team. Review manufacturing batch records. Maintain the internal training database and coordinate quality training activities. Initiate, follow up and close concessions, deviations, change control and CAPA (corrective and preventive action). Supplier Assurance: Monitor and evaluate supplier performance. Perform goods inwards quality inspections of purchased incoming raw materials and consumables. Ensure traceability of inventory and products is maintained including physical checks within the warehouse and laboratories. Work environment: Support the facility team with remote environmental monitoring system and perform cleanroom particle count measurements to ensure cleanrooms meet requirements of ISO Class 7. Perform physical checks on production areas and equipment, including cleaning and maintenance records and calibration status. Auditing: Support internal audits. A training pathway will be put in place to develop your capability in this area. The experience and skills: Experience of working in a quality-assurance department preferably in an ISO 9001 and or ISO 13485 certified organisation. Working knowledge of Quality Management Systems, Change and Document Control, CAPA and Customer Complaints. Self-motivated, resilient, and able to organise own workload and manage competing priorities A strong attention to detail. Excellent written and verbal communication skills. Competent with MS Office software (MS Word, PowerPoint, Excel etc.) and project management software. Desirable Skills Internal Auditing Software verification and auditing experience would be advantageous. Please note: Only candidates with the relevant skills and experience will be contacted regarding this position. If you do not hear back from us within 5 days you have unfortunately been unsuccessful in your application for this position, however we may contact you in the future to discuss other opportunities. Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.