What you need to know:
Our client, a reputable and globally renowned medical devices company based in Co. Westmeath is currently seeking a Quality Systems Engineer to join its Quality team.
As a Quality Systems Engineer, you will report directly to the Quality Manager and work collaboratively with your colleagues in the quality team to ensure quality systems are maintained, adhered to, and improved. You will be responsible for representing the Quality department at site meetings and will guide technical activities related to documentation, process updates, and validations.
This is a Permanent role with an excellent salary and package.
Your new job
Key duties & responsibilities include:
Represent the Quality department at management meetings when required.
Acting as a delegate for the Quality Manager on site.
Lead and implement significant process improvements, projects and cost-saving initiatives using data & quality tools to drive quality decisions.
Initiating, reviewing, approving, and providing guidance on change controls and change control processes.
Performing, analysing and interpreting statistical data by using statistical tools and methods.
Lead investigations and provide technical guidance to peers in relation to CAPAs and NC and address compliance issues.
Ensuring QMS is implemented and adhered to by completing an independent assessment of QMS documentation as required.
Provide periodic training for company personnel on the company’s Quality System processes and procedures.
Performing and leading Internal and Supplier Audits.
Facilitating and participating in external regulatory body audits, e.g., ISO and FDA
Implementing KPIs in the Quality Assurance function to align with site and global quality objectives.
Actively lead QMS Process Improvement Projects
Following strict adherence to the requirements of CGMP.
Ensuring compliance with quality systems and all applicable regulations, and internal procedures.
What are we looking for?
A minimum of a level 8 Degree in Engineering or Science.
A minimum of 5 years’ experience working in a regulated manufacturing environment, ideally medical device.
Lead Auditor or Internal Auditor certification is a distinct advantage.
Strong knowledge of statistical tools and techniques
Strong knowledge of FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
Excellent knowledge of problem-solving techniques with the capability to use them effectively.
Ability to effectively communicate highly technical information, both verbally and in writing, to non-technical and technical colleagues.
Knowledge of Quality System Regulations and associated regulations and standards.
Outstanding attention to detail and accuracy.
Strong analytical reasoning and the ability to work well to tight deadlines.
Excellent organisation and project management skills.
Ability to effectively prioritise tasks and manage multiple projects simultaneously.
Apply for this job now with a Word version of your CV or get in touch with Oliver at email@example.com
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