Are you a quality engineer with 3-5 Years of experience, who has a flair for quality systems and validation? If so then this permanent position based onsite in Westmeath is calling you!
You will get the opportunity to work with leading brands like Tesla, BMW, Xerox and Abbott to design, manufacture and deliver sustainable products for the vehicles and equipment of the future. Our client deeply cares about their colleagues, customers and community and has a curiosity that constantly pushes their team to innovate and improve.
Scope of the position:
Provide Quality Assurance expertise to the Quality department – Plant 1 to ensure the Quality System is of the highest standard. Safeguard the quality of all products produced in Plant 1 through NCR/ CAPA and complaint investigations to ensure all customer & regulatory requirements are met.
- Maintain a quality system compliant to the ISO13485: 2016 standard and all applicable regulations under associated Directives.
- Maintain the document control system to ensure the control of quality system documents and records as per the requirements of the relevant international standards.
- Co-ordinate/ perform investigations on production related issues in conjunction with QC Technicians to ensure all customer & regulatory requirements are met.
- Maintain all quality system metrics for reporting at Management Review.
- Maintain and manage the calibration system as required.
- Maintain and manage training related to quality management system documents.
- Internal audit team leader. Schedule, track and ensure timely completion of internal audits.
- Track completion of all activities associated with all open non-conformances (NCRs) & CAPAs.
- Support the batch file review and approval process as required.
The ideal candidate will:
- Have a relevant 3rd level qualification in Engineering or a related field
- Minimum 2-3 years experience in a manufacturing environment.
- Previous experience in an ISO13485 regulated manufacturing environment would be a distinct advantage.
- Experience with quality systems and validation would be a concrete benefit
- Medical device manufacturing experience is desired but not essential
- Strong attention to detail with a structured approach to planning & organising
- Be able to work on own initiative and priorities work as required
- Have excellent communication skills
Excellent Benefits package on offer:
- 4% Company Pension Contribution
- 26 days annual leave
- Educational support & assistance
- Sports & Social - Strong community/family feel with Employee/Family events throughout the year
For a confidential discussion about this opportunity please contact Ranait Coughlan
(090) 6450664 (01) 66 200 88