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. Flexicare has ambitious plans for international growth and we want you to be a part of our journey!
What You'll Do
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
* Lead the development of new systems and procedures
* Plan, conduct and supervise closure of complaints, FSN, vigilance reports
* Support continuous improvement activities
* Drive KPI delivery in complaint process
* Actively support team development within quality to increase performance and engagement
* Support CAPA and NC initiation and execution
* 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
* Advocate of Human Factor practices, familiarity in the science of Human Factor Identification, reduction and mitigation
* Develop understanding of risk management practices and concepts
* Develop proficiency in statistical methods and application
* 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
* Ensure device traceability of returns
Who You Are
We believe you're the right fit if you have
* Level 6 qualification in a science, engineering or related Advanced degree preferred
* Master's degree or equivalent
* Minimum 5 years experience
* 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
* Leadership skills
What You'll Get
* 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.
Applications close on Friday 7th March 2025