Project Lead Quality Operations
il y a 1 semaine
PROJECT LEAD QUALITY OPERATIONS
- Medical Devices
- KortrijkWHAT IS OFFERED
We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance.
We provide personalized training to let you grow in the area of
- What you like to do
- What you are good at
- Where and how you want to have an impact
ABOUT THE COMPANY
MindCapture collabs with an innovative, Belgian biotech company specialised in digital imaging technologies. They help medical professionals
enable better health outcomes and work more efficiently in an increasingly complex healthcare enterprise. Their extensive line-up of
high-precision medical monitors brings accuracy and efficiency to a broad range of healthcare disciplines. They offer display systems designed specifically for various disciplines.
As a consultant at MindCapture you'll be supported by us and our partner.
We provide on the job trainings and personal support so that you can grow both horizontally and vertically throughout your career.
We are looking for a motivatedproject lead to support the
quality operations department at our customer's side. As a project lead, you'll be involved in both medical and non-medical quality management (ISO13485 & ISO9001).
Medical (ISO13485):
- Design control & CAPA improvement
- Participate in NPI projects as Quality delegate and acts as Quality gatekeeper in NPI stage gate review meetings.
- Execute Quality Assurance responsibilities in medical devices risk management process and review technical documentation on sample basis.
- Facilitate improvements and corrective actions (CAPA) with main focus on product corrective action processes.
- Propose, support and lead improvement initiatives (short/midterm) for processes and practices.
- Report process and product performance figures, deviations, progress on quality performance or the need for improvement and implement changes in line with the divisional quality plan and objectives
- Person has the authority to withdraw nonconforming products, set and release production or delivery holds
Non-medical (ISO9001):
- Define and work out a product quality inspection process (both in line inspections of subassemblies and out of the box inspections) in the projection manufacturing.
- Identify independent QA inspection requirements, based on the occurrence of failure modes and criticality.
- Define where and how the QA inspections can be executed, incl reporting
- Define the required tooling and competences
- Bachelor's or master's degree in an applied science such as biomedical engineering, physics or equivalent by experience
- At least 3 years experience in design control within medical devices and/or quality manufacturing
- Knowledge of ISO13485 and ISO900
- Collaboration, communication & motivation skills
- Critical & analytical thinking
- Organisation & reporting skills
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