Internal & Supplier Quality Auditor - United Kingdom
Division: Manufacturing (KeyMed)
As part of the Olympus global manufacturing community, Olympus KeyMed's Manufacturing Business Centre plays a key role in the development and manufacture of new, sophisticated medical and industrial products. Working with colleagues in Europe, the USA and Japan, our multi-disciplinary team of R&D engineers is fully equipped with the latest computer-aided design and modelling technologies, to enable them to develop medical workstations and fluid management products & accessories, and industrial Remote Visual Inspection devices.Producing world class products in terms of Quality, Cost and Delivery isn't just desirable, it's essential. Therefore, in today's fast moving, ever changing world, we continue to invest in both our people and the latest equipment and processes to remain at the forefront in manufacturing technology.
- Define, manage and lead an internal/supplier audit programme for the quality management system and complete audits according to the plan
- Ensure actions as a consequence of audits are completed within specified timescales
- Ensure continued regulatory compliance to international regulations and standards
- Provide internal auditor training
- Ensure supplier audit file are complete including ISO certificates and other relevant documents.
- Provide and present regular detailed management reports .
- Lead and Support 3rd party audits (MDSAP)
- Represent the company during external audits e.g. FDA, Notified Body
- Educated to a higher technical qualification in an engineering, science and/or business related subject e.g. Bachelor degree or equivalent.
- The position holder must be a trained auditor, preferably through an IRCA recognised course or equivalent to MDSAP and/or ISO 9001:2015 and ISO 13485:2016.
- Must be an excellent communicator both verbal a written. Must have expert knowledge of QMS standards/requirements and quality engineering.
- Experience of auditing and assessing to multiple standards and regulations with a particular emphasis on quality management. Able to work under minimal supervision and make decisions for work priorities.
- Minimum of 10 years’ experience within a Quality Assurance/Regulatory Affairs role.
The interview will be competence based and the following competencies will be assessed:
- Customer Centricity
- Employee Focus
- Operational Excellence
- Social INvolvement
All applications must be received by the closing date of 19.02.2018 and will not be accepted after this deadline.
Should you have been referred to Olympus by a current employee, please email email@example.com to confirm the employees' name and the role you are applying for at the time of submitting your application.
You will be required to provide evidence of your eligibility to work and reside in the UK, in accordance with the requirements of Section 15 of the Immigration, Asylum and Nationality Act 2006.
At Olympus, we have a dedicated in-house recruitment 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 (which is now closed to new suppliers). Please note that Olympus will not be responsible for any fees, charges or terms associated with any such CVs. CVs will only be accepted from approved agencies where terms and conditions have been agreed and we have instructed them to work on specific positions.