In Utrecht, you will safeguard quality across production and product development. You will maintain the QMS in line with ISO 13485, support audits and CAPA, and work on risk analyses and process improvement.
The role
At our client company in Utrecht, you will safeguard quality across production and product development. The role combines hands-on work with advice, with a focus on implementation and day-to-day operational quality assurance.
Your responsibilities
- You will maintain and monitor the Quality Management System (QMS) in line with ISO 13485 and keep SOPs up to date.
- You will conduct risk analyses and FMEAs and implement appropriate control measures.
- You will support and coordinate internal audits, prepare for audits by notified bodies, and support external audits and certification and inspection processes. You will work to applicable product-safety requirements and customer audit requirements.
- You will manage CAPA processes: investigate deviations, set clear action plans, track actions through to completion, and ensure deviations are closed.
- You will carry out operational quality checks and monitor KPIs such as first pass yield, CAPA response time and non-conformance rate. You will use eQMS and ERP data, supplemented by manual checks.
- You will work on improvement projects and coordinate daily with production and engineering. You will also work with supply chain and management.
- You will influence process changes and production release, advise on supplier selection and product decisions, and escalate deviations to management when needed.
Requirements
The available role information does not specify particular education, experience or certification requirements.
Practical details
The work location is Utrecht, Utrecht province. Contract type, working hours, shift pattern and salary are not specified.