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Flexicare is a leading designer and global provider of medical devices that enhance patient care with over 35 years of experience. Headquartered in the UK, we support clinicians worldwide with class-leading devices and a global network of subsidiaries across more than 100 countries. We have ambitious plans for international growth and want you to be part of our journey.
Your Key Responsibilities
You will ensure compliance of products and processes with the following regulatory standards:
* ISO 13485
* ISO 9001
* FDA
* MED DEV 93/42/EEC
* MDR 2017/745 (when applicable)
Additionally, you will maintain compliance with customer requirements, handle complaint intake, conduct investigations, and decontaminate equipment.
* Decontamination process maintenance
* Q-Pulse record maintenance
* Authority to stop batch/line production pending investigation of quality issues/non-conforming product
* Use of test equipment, both electronic and mechanical
* Adhere to company procedures in line with good documentation, manufacturing and engineering practices
* Improvement/reduction in complaint KPIs
* Improvement/reduction in complaint investigation processes
Your Qualifications and Experience
We are looking for an individual with:
* Knowledge of ISO 9001; ISO 13485; FDA, MDD/MDR, GMP
* 1-2 years of experience
* Good communication skills - both oral and written
* Computer skills
* Product knowledge is desirable
What We Offer
We offer:
* Competitive salary in accordance with experience and capabilities
* Pension
* Company performance bonus (paid annually)
* 33 days holiday per year (including bank holidays) plus holiday trading scheme
* Benefits package: life assurance (x2), income protection (50% of salary), health cash plan (Medicash), benefit pot - for spending on additional benefits
Please note that applications close after this posting.
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