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Quality Engineer - Complaints

KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Corporate

Type of employment:

Permanent employment

Function:

Quality / Audit / Corporate Governance

Location:

Southend-on-Sea, England, United Kingdom

Reference Number:

80036191-07052024

Website:

https://www.olympus.co.uk

Working as part of the Post-Market Quality and Vigilance function, in this role you will focus on products manufactured by Olympus in the UK & Ireland, ensuring that complaints are evaluated and investigated in a timely manner.

Your responsibilities

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

Your qualification

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

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!

About Olympus Corporate

The Corporate Division is responsible for centralized functions that include Finance and Controlling, HR, IT, Quality Management and Supply Chain Management. It provides essential services and support to all business divisions. Moreover, it is an important project initiator and leader within the international network.

Further information:

We are an equal opportunities employer, and we are committed to ensuring that no applicant or employee receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements which cannot be shown.

At Olympus, we have a dedicated in-house Talent team that cover all areas of the business. As a backup, we have a preferred supplier list (PSL) of vetted suppliers and as such, are unable to accept unsolicited CVs from recruitment agencies or search firms outside of our PSL. Please note that Olympus will not be responsible for any fees, charges or terms associated with any such CVs.