Become Part of the Team With over 35 years of experience, Flexicare is a leading designer and global provider of medical devices that enhance patient care. Headquartered in the UK, we support clinicians worldwide with class-leading devices and a global network of subsidiaries across over 100 countries. You will lead quality engineering activities in the management of complaint handling and associated post market activities, such as Field Safety, Vigilance and Trending to ensure the highest level of customer quality experience post market.
Lead process to support products in customer experience post market, including complaint investigation, corrective action, preventive action, FSN, vigilance and post market surveillance
Plan, conduct and supervise closure of complaints, FSN, vigilance reports
Drive KPI delivery in complaint process
Actively support team development within quality to increase performance and engagement
Work closely with design, operations and other business functions to ensure quality performance of products
Work closely with customers, sales/marketing/field personnel and cross-functional teams to address top quality issues
Maintain KPI's for monitoring of process and/or product quality, perform analysis and interpret trends and take action as necessary
Develop understanding of risk management practices and concepts
Engage and interface in internal audits providing effective narrative and description of the topic expertise, participate in external audit preparation building confidence and proficiency in interactions
Responsible for the initiation, internal containment and support of ship and product holds for potential product escapes
Level 6 qualification in a science, engineering or related Advanced degree preferred
Master's degree or equivalent
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA and International requirements
Demonstrated technical knowledge of medical device product lines
Knowledge of adverse event reporting, complaint investigation, CAPA and corrective action processes
Competitive Salary in accordance with experience and capabilities
~ Pension
~ Company performance bonus (paid annually)
~33 days Holiday per year (incl Bank Holidays) plus Holiday Trading Scheme
~ Benefits package: Life Assurance (x2), Income protection (50% of salary), Health Cashplan (Medicash), Benefit pot - for spending on additional benefits, which include: Upgrade Health Cash plan, Critical Illness cover, Cycle to work, Tech Benefits, Will Writing, Or add it to your pension pot if not used.