Description
I have a fantastic opening for a Senior Quality Engineer with a leading medical device company based in Co Offaly, strong experience with Quality Systems is essential.This is an excellent opportunity to join a rapidly growing company, this is a vital role for the company and this person will be the Deputy to the Senior QA Manager, and will act as the Site POC when the manager is absent.
Key role of this position is to proactively support quality engineering activities with regards to the Quality Management System, product robustness changes and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations. This is an essential function in the overall strategy for improved assurance of continuity and improvement of the established QMS, delivered product quality and to support growth of the Company.
DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
* Provide active management of the supporting elements of the Quality Management system.
* CAPA Management, management of the CAPA program and support Engineering and Manufacturing teams and lead CAPA investigations as required.
* Experience with management of Document Control system, internal audit programs, nonconformity systems and supplier management program.
* Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies.
* Drive and implement plant wide quality system improvements.
* Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
* Deputize in absence of Snr QA Manager.
* Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on site and across the Corporation where relevant.
* Collate and trend quality data relating to product robustness, conduct analysis and recommend necessary technical solutions to drive effective corrective action.
* Conduct detailed root cause analysis on design related non conformances, developing effective preventive measures to prevent recurrence.
* Approval of change requests for product, process and quality system changes.
* Conduct Internal Audits against schedule as part of Audit Team.
* Participates in external regulatory audits in areas of their responsibility.
QUALIFICATIONS/EXPERIENCE
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
* Engineer/Science qualification (Minimum BSc or BEng) with minimum of 5 years working within QA in a multi-national medical devices manufacturing environment.
* Excellent working knowledge of ISO 13485 and 21CFR820, along with exposure to other regulations. Working familiarity with IEC 60601 a distinct advantage.
* Experience in leading CAPA program, and other quality management systems and experience with leading and participating in several projects concurrently.
* Ability to accurately scope projects and consider the full impact of decisions and actions taken.
* Attention to detail and accuracy - essential.
* Ability to work well under deadlines and pressure.
* Strong Problem solving skills for developing creative solutions and meeting objectives are required.
* Experience in internal auditing to QSRs and ISO 13485 requirements.
* Supervisory experience required.
If you are interested in hearing more about this excellent opportunity apply directly to this advert for immediate consideration.