My Tullamore based client is looking to bring on board two Quality Engineers in the New Year and will be looking for candidates who have previous experience with medical device/medical device packaging industry and also some experience with Auditing and NSAI Quality standard 13485. So whether you’re senior level or just have a year or two experience in industry, then read on and if it sounds like a good fit for you, get in touch.
This is a permanent job.
Your new job
You will be reporting to the Quality Manager and you will be responsible for the Maintenance and continued improvement of the Quality Management System. The structure of the operations is made up of three separate standards; Medical, Oral -care & Cosmetics.
Key duties & responsibilities:
- Responsible for Record Management, Deviations, CAPAs, SCARS, Non-Customer complaint evaluation, analysis, reporting and timely closure.
- Complaint trending and monitoring of corrective actions
- Manage / execute site quality systems including CAPA, internal and supplier auditing, product release and validation activities.
- Lead Problem Solving, Failure & Root Cause Analysis, Risk Assessment & FMEA activities within the Team.
- Foster a culture of continuous improvement and support the implementation of SIX Sigma and Lean Initiatives on site
- Provide leadership/mentoring of all Quality team members
- Act as Subject Matter Expert with respect to Internal/External Auditing for the site
What are we looking for?
- Relevant qualification in Engineering/Quality
- Demonstratable experience working in the Medical Device industry
- Good knowledge of regulatory standards including ISO 9001, ISO 13485, ISO 14971
- Attention to detail and enjoys problem solving
- Strong communicator and able to work with other areas of the organisation
- Provide leadership and guidance as a subject matter expert
Apply for this job now or get in touch with Gareth on 090 6490485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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