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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

    • 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.

    Your competencies
  • 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


    • Your benefits
  • 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!