QA Project Manager
Full-timeSeniorQuality AssuranceNeurology
Market Rate — Compliance Officers
25th
$59K
Median
$76K
75th
$101K
BLS 2024 data (national)
Description
- Implement, maintain and manage a company wide QMS based on ISO 13485.
- Responsible for all QA/RA activities including: CAPA, MRB, ECO, training and supplier management.
- Perform internal and suppliers audit and prepare the company for regulatory audits.
- Create Quality Metrics and prepare for Management Review.
- Develop company wide training and documentation materials to enable the seamless knowledge transfer of project and manufacturing processes.
- Establish and maintain design control processes including risk management according to ISO 14971.
- Responsible for contact with regulatory authorities including regulatory submission and compliance.
- Provide quality guidance and leadership to other team members.
Requirements
- At least 4 years’ experience maintaining quality systems in the medical device industry.
- Experience in writing and maintaining DHF related documents.
- Experience in writing and maintaining design controls and risk management processes.
- Experience in writing and implementing Quality Procedures.
- Experience in quality related processes such as: CAPAs, MRB/NCR, in process tests and final release.
- Knowledge in industry related standards and their interpretation.
- Experience in writing and submitting regulatory documents.
- Participation in regulatory audits.
- Familiar with 62304
- Quick learning ability and independent workers.
- Languages: strong commend of English (reading, writing and speaking).
BrainQ
MEDICAL DEVICES
AI-powered, non-invasive wearable device delivering frequency-tuned electromagnetic field therapy
LocationIsrael - Jerusalem
Employees1-50
Open Jobs1
Neurology
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