Founded in 1989, Flexicare is a global medical device company specialising in airway management and respiratory solutions, supported by a complementary portfolio that extends across critical care, respiratory technique and urology, giving us on the of the broadest ranges in our sector.
Become Part of the Team
Based at our HQ in Mountain Ash, you will join our global Quality team on a 9-month fixed term contract to ensure products and processes compliance is maintained on the following: ISO 13485, ISO9001; FDA; MED DEV 93/42/EEC and MDR 2017/745 (when applicable) and any other regulatory compliance required by the business along with customer requirements.
What You’ll Do
- Complaint sample intake and processing of packages and accompanying paperwork such as shipment information, decontamination certificates etc.
- Complaint investigation follow up and support, including risk evaluation, vigilance decision making, sample request, and complaint review for closure
- Where required, decontamination process maintenance in QMS and physical environment for returned complaint samples
- Q-Pulse record maintenance for complaint proves and any other associated tasks as assigned such as CAPA, NC related to the complaints or production process
- Executes vigilance activities by assessing events for reportability, making reporting decisions, and preparing, submitting, and tracking regulatory vigilance reports in accordance with applicable requirements and timelines
- Use of test equipment, both electronic and mechanical to support complaint investigation
- Adhere to company procedures in line with good documentation, manufacturing and engineering practices
- Support improvement initiatives for reduction in complaint KPIs and support reporting of complaint KPIs for the PMS function
- Supports PMS activities, including maintaining PMS plans and trackers and coordinating inputs and timelines to support periodic safety update report (PSUR) preparation and submission
- Authority to stop batch/line production pending investigation of quality issues/non-conforming product
Who You Are
We believe you’re the right fit if you have
- Knowledge of ISO 9001; ISO 13485; FDA, MDD/MDR, GMP
- 1-2 years experience
- Good communication skills – both oral and written
- Organisational skills
- Product knowledge is desirable
What You’ll Get
- Competitive Salary in accordance with experience and capabilities
- Pension
- 33 days Holiday per year incl Bank Holidays (pro-rata for FTC)
- 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.
Due to the high volume of applications anticipated for this role, we regret that we will only contact candidates selected to progress to the next stage of the recruitment process.
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