Medical Device QA Mng / QARA / QA Engineer

Company Description

HaMaDa is a Consulting Firm with 17 years of Regulatory, Compliance and Clinical Affairs expertise in teh Medical Device, SiMD, SaMD, AI, ML & Digital Health Markets Our seasoned consultant supported over 350 customers over these years.

QARA Professionals:

We offer to QARA professionals in the Medical Device industry a high profile and exciting job, learning how to operate as a consultant and widening and deepening your professional capabilities.

Role Description:

Establish, improve, and maintain QMS Systems, from design to manufacturing and distribution stages of the company. Lead vendor processes.

Support CE and FDA certification processes.

Prepare documents and design technical documentation in support of CE marking (MDR or IVDR), FDA submissions, or rest of the world based on the company strategies.

Among your duties you may be requested to:

• Create Technical File/Documentation for all device classes and various geographies.
• Establish and/or maintain Quality Systems.
• Prepare & submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions.
• Lead Risk Management processes.
• Support design and development of products from a quality and / or regulatory perspective.
• Develop or support DMR, DHR, DHF
• Prepare annual planification’s for quality and regulatory activities (i.e. trainings, audits…)
• Advice on standards i.e. labeling UDI requirements.
• Lead or support special processes such as sterilization, cleaning, biocompatibility etc. –planning and managing the process to success.
• Participate in internal and external audits according to ISO13485, EU MDR, MDSAP.

Desired Experience & Skills

• Minimal 3 years working experience in various areas of Medical Devices
• Knowledge of the various stages of the product life cycle: design, clinical trials, manufacturing, and distribution phases
• Knowledge of Medical Device Quality and Regulatory requirements
• Ability to deliver results. Effective communication, collaboration, and flexibility to learn new work environments and relationships with customers.
• Technical or scientific degree (BSc, MSc or PhD)
• Fluent in English.