- Improvement/reduction in complaint investigation processes in relation to quality and timeliness of investigations.
- Adhere to company procedures in line with good documentation, manufacturing and engineering practices
Client Details
With over 35 years of experience, my client has supported clinicians worldwide to enhance patient outcomes with class leading devices. A leading designer and global provider of medical devices.
Headquartered in the UK, our global network of 15 subsidiaries supports over 105 countries with dedicated in-market clinical experts and customer service centres.
Our regional teams are committed to providing swift solutions tailored to individual requirements.
Description
- Complaint Sample Intake and processing of packages and accompanying paperwork.
- Complaint investigation follow-up and support
- Decontamination process maintenance in QMS and physical environment
- Q-Pulse record maintenance for complaint process and any other associated tasks as assigned such as CAPA, NC related to the complaints or production process
- Authority to stop batch/line production pending investigation of quality issues/non-conforming product.
- Use of test/decontamination equipment, both electronic and mechanical.
- Adhere to company procedures in line with good documentation, manufacturing and engineering practices.
- Support improvement initiative for reduction in complaint KPIs
- Improvement/reduction in complaint investigation processes in relation to quality and timeliness of investigations
Profile
- Working knowledge of ISO 9001; ISO 13485; FDA, MDD / MDR, GMP
- Communication skills - both oral and written.
- Computer literate.
- Organisational skills
- Approximately of 1-2 years' experience within Medical Device or allied/similarly regulated industry, or laboratory environment
- Demonstrated written, verbal, listening, communication, and team-building skills.
- Demonstrated ability to collaborate effectively with functional teams.
- Demonstrated ability to effectively prioritise and manage multiple project workloads with minimal supervision day to day.
- Demonstrated process improvement and management skills.
- Influence across the organisation.
Job Offer
- Salary
- Great progression opportunity