Who we are?
At Mergon, we mould ideas for a sustainable future. We 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.
We care deeply about our colleagues, customers and our community and we have a curiosity that constantly pushes us to innovate and improve. We are competent, capable and we invest in our people and in our processes to ensure we continue to grow and do our best work every day.
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.
What we are looking for:
- Have a relevant 3rd level qualification in Engineering or a related field
- Min 2/3 years experience in a manufacturing environment.
- Previous experience in an ISO13485 regulated manufacturing environment would be a distinct advantage.
- Strong attention to detail with structured approach to planning & organising
- Be able to work on own initiative and priorities work as required
- Have excellent communication skills