Quality Control & Compliance role (Part time)
# Quality Control & Compliance role (Part time) **Fairfax Medical Products Ltd.** · Hemel Hempstead HP1 2UJ · `On-site` 🕒 **Статус:** *Опубликовано: 3 дня назад* · *Источник: Indeed* --- ### About the Role Fairfax Medical Products Ltd is a small manufacturer dedicated to quality, reliability, and customer service. We foster a friendly, supportive workplace where we appreciate every team member. As a medical product manufacturer, we uphold high standards and provide clear instructions, practical training, and ongoing support to our staff. Role and Main Responsibilities Working with Quality Management consultant Maintain the ISO 13485-accredited Quality Management System (QMS). Ensure compliance with applicable national and international standards and regulations, including ISO 13485 and 21 CFR 820. Maintain accurate, up-to-date, and accessible records and procedures required by ISO 13485 and CFR 820. Ensure company quality policies and procedures are implemented and followed by all employees. Promote awareness of regulatory requirements and quality practices throughout the organisation. Manage Corrective and Preventive Actions (CAPA), non-conformances, and complaints, from initiation through resolution, including root cause analysis and effectiveness checks. Prepare and present annual trend reports on CAPAs, non-conformances, and key quality indicators. Review, update, and maintain Standard Operating Procedures (SOPs) to ensure QA and production processes remain compliant, accurate, and well-communicated. Manage document and product change controls from initiation through approval and implementation. Support internal and external audits, including preparation, execution, reporting, and close-out activities. Review and maintain supplier and customer quality documentation, including verification of purchased products, approval of reports/results, and compliance checks. Oversee calibration and maintenance schedules to ensure timely execution. Support validation activities for new equipment and processes. Liaise with notified bodies and competent authorities as required. Support regulatory submissions, registrations, market approvals, and reporting to authorities. Skills and Experience Essential · Basic knowledge of computers and Office 365 Working knowledge of ISO 13485. Being able to work within an established Quality Management System. Desirable Experience in a Quality Management System role within the medical device industry. Experience working in controlled environments (e.g., cleanrooms). Knowledge of sterilisation processes. Experience preparing and maintaining technical documentation (MDR). Working knowledge of MDR and UK MDR 2002 Pay: £15.00-£18.00 per hour Expected hours: 16.0 – 24.0 per week Benefits: Casual dress Free parking On-site parking Experience: Quality Managment System ISO 13485: 1 year (required) Work authorisation: United Kingdom (required) Work Location: In person
Наблюдалась 2026-09-21, впервые 2026-09-18, источник — Indeed.