Quality Engineer - Complaints
Olympus KeyMed Group Companies
Quality Engineer - Complaints
Salary Not Specified
Olympus KeyMed Group Companies, Prittlewell, Southend-on-Sea
- Full time
- Permanent
- Onsite working
Posted 2 weeks ago, 16 May | Get your application in now before you miss out!
Closing date: Closing date not specified
job Ref: 1388340cec574b56bf7e248f8515bcae
Full Job Description
- Interpreting data trends resulting from complaints and ensuring negative trends undergo the CAPA Risk Review process
- Maintenance of Complaints Master Data and input for Risk Summary Application - ensuring the up-to-date key data relating to products manufactured in UK&I is available at all times
- Support the Post-Market Quality team with managing Complaint processes
- Directly responsible for evaluating complaints, conducting and documenting complaints investigation
- Where necessary, review and approve complaint investigations and ensure these have been conducted to the documented standard
- Management of product returns with focus on cost-effectiveness of the return
- Development and maintenance of Risk Summary Application input (library of fault codes and associated risk evaluation) for products manufactured
- Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system
- Support R&D activities and Post-Market Surveillance activities, especially in the area of data trending and overviews for manufactured products
- Produce relevant reports and presentations, including Post Market Surveillance and Health Hazard Evaluations
Bachelor's degree or equivalent, in an Engineering or Scientific discipline - Experience in Medical Device vigilance investigations and reporting is essential
- Knowledge of ISO 13485 and FDA Quality System Regulations
- Ability to interpret data trending related to product complaints
- Ability to work independently as well as part of a team
- Patient Focus - We put patients at the heart of everything
- Integrity - We do the right thing
- Innovation - We look for new ways to make things better
- Impact - We take accountability and get things done
- Empathy - We care for one another and work together
- In addition to a competitive salary, you will receive a generous annual leave entitlement that increases over your length of service
- You will be eligible to receive private medical cover
- Comprehensive company pension scheme
- You will be entitled to an annual health check
- At our HQ, we have a subsidised staff restaurant and free parking
- Other benefits include flexible working hours, discounted gym membership, cashback and discounts, enhanced parental leave and so much more!
Please be aware, this role is office based but may require manual handling on occasion related to product complaints/investigations. On occasion, you may be required to review new complaints outside of your normal working hours.
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