Who we are?
At Mergon, we mould ideas for a sustainable future. We work with leading brands like Abbott, Beckman Coulter, Fresenius & Tesla to design, manufacture and deliver sustainable products for the 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.
What’s the job?
We are currently looking for a Quality Engineer to join our growing team. Reporting to the Quality Assurance Manager, you will be the quality representative working to ensure that we continue to meet all customer & regulatory requirements. This role is focused on ensuring ongoing compliance to the ISO standards ISO13485, ISO9001 & IATF16949. This individual must have strong technical ability, problem solving skills, and communication skills to help troubleshoot, diagnosis, and solve issues during new product introduction and general manufacturing.
- Monitor CAPA/ NCR process, ensure timely closure of CAPAs and champion a structured approach to problem solving to drive effective root cause analysis. This will be completed through mentoring/ training personnel on requirements and holding regular CAPA meetings to drive investigations and thorough root cause analysis.
- Lead all PFMEA & risk assessment activities to eliminate or reduce risks to product quality
- Responsibility for investigations into Product/Process non-conformances and customer complaints with a particular focus on medical products.
- Perform an active role in quality planning and new product introduction. Lead validation activities for the introduction of medical products & equipment.
- Lead cross functional teams in managing change controls across the Plant.
- Member of Internal audit team to assess quality system compliance to ISO13485: 2016.
Who we’re looking for?
- BS or BEng in mechanical engineering, quality engineering, manufacturing engineering, or other technical discipline.
- 5 or more years’ experience,
- Strong written and verbal communications skills and interpersonal skills
- Confidence in dealing with customers
- Demonstrated problem solving skills including 8D
- Demonstrated ability to utilize Six Sigma tools (FMEAs, Gauge R&R, Capability Analysis, Statistical Process Control) and statistical tools (Minitab, etc).
- Experience in generating & approving validation protocols & reports (DOE/IQ/OQ/PQ)
- 6 sigma green belt training would be a distinct advantage.
Mergon is an Equal Opportunity Employer that offers flexible working arrangements and values a diverse and inclusive workplace.