My client a well respected international medical device manufacturer are seeking an experienced Senior Quality Engineer Management Systems.
The primary responsibility of the role is to organise and lead on a day to day basis the company's quality systems, to the requirements of regulated standards. To maintain certification to these standards as required, by administration of the management system, driving actions and facilitating others to ensure compliance.The job role is best suited to a very motivated, well organised person. The individual will lead and work with various departments in order to develop integrated processes and procedures which work for the business, but comply with the requirements of standards.
- Implement and maintain the company's Business Management Systems ensuring compliance to ISO9001, 14001, OHSAS 1800/ISO 45001
- ISO 13485 and FDA QSR experience in desirable but not essential as full training will be given
- Support the transition to 45001 in conjunction with the HSE Advisor
- Implementing ISO 13485
- Liaising with external certification bodies (or enforcing agencies such as FDA) to maintain/again certification and approval as required
- Management and implementation of the internal audit programme for QHSE, including ad hoc process audits as the need demands, including ensuring legal compliance audits are conducted as required.
- To locally implement and monitor Group QHSE Policies and Processes, ensuring embedding and approval of all QHSE documents
- Ensuring DMR information is suitably controlled and issued
- Lead the internal audit program, conduct internal audits and drive associated improvement activity.
- To be the representative for system and product certification audits and reporting.
- Auditing experience in any of: ISO 9001, ISO 45001, ISO 14001 and ISO 13485 and FDA Part 820 Quality System Regulation - ideally lead auditor trained
- Medical device regulatory experience or qualification
- Knowledge of ISO9001
- Knowledge of any of: ISO 45001, ISO 14001 and ISO 13485 and FDA Part 820 Quality Systems is desirable not essential
- Medical Device quality systems experience would be beneficial
This role would suit an experienced Quality Engineer or Senior Quality Engineer seeking to progress their career in Quality Systems Management. Please apply as soon as possible to be considered for this desirable Quality Engineering position.