ELMindA Published: January 28, 2019
Job Type
Category
R&D, QA,
Level of education
Undergraduate
Spoken Language needed
English
Level of Hebrew
Medium
Location of job
Herzliya
How many relevant years experience do you require for the role:
More than 3 years

Description

ElMindA, a leading company in the brain health technologies is looking for an experienced and passionate QA/RA Manager. You will join a dynamic and fast-paced environment and work with cross-functional teams to design, build and roll-out products that deliver the company’s vision and strategy.

Responsibilities
- Oversee and maintain the company’s Quality Management System QSR/GCP program. Propose and initiate continuous improvement practices
- Implement European regulations ISO 13485:2016
- Conduct and scheduled periodical Quality Management Reviews
- Gather and Analyze product use and failure, customer feedback and complaints, and recommend appropriate changes in product
- Maintenance and implementation of company procedures and quality process, update procedures and verify proper use, functionality and efficiency
- Monitor product development activities and documentation, especially Design Control activities, Design Review meetings, Risk Analysis meetings
- Manage DHF, DMR, ECO/DCO processes and complaints, including expansion of DHF scope
- Management and responsibility of the Corrective and Preventive Action System (CAPA), including investigations and timely completion of corrective actions
- Qualify and Requalify, when appropriate, company Suppliers
- Continuously update, maintain, and oversee the company’s Quality Document Control system
- Train new employees, maintenance of Employee Training Records, and follow company training program.
- Maintain HIPAA/GDPR awareness and training and investigation of HIPAA/GDPR breaches when necessary
- Implementation of digital quality management system
- Management of software and QA consultants
- Manage submissions for additional markets

Requirements

- Academic education (preferably Biomedical Engineering)
- Proven 4-5 years of employment experience in QA/RA in medical device companies.
- Proven 3 experience with medical software development and certification.
- Hands on experience with ISO 13485, ISO 14971, IEC 62304 etc.
- Languages: Hebrew, English – fluent.
- Accurate, Organized, Multi-tasking and Responsible, positive management attitude and collaboration with different teams.
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