#Quality Assurance Lead - ISR
Who are we?
We are here to improve the lives of patients through innovative technologies. We're a rapidly growing inter-disciplinary team of professionals passionate about developing disruptive technologies that use the body’s immune response in order to empower physicians to make better informed decisions. Our first goal is to address one of the most frequent medical encounters – the fever encounter (www.me-med.com).
Who are we looking for?
If you are a talented Quality Assurance expert, with exceptional make things happen approach, a drive for excellence and with the experience of leading and executing quality assurance activities, then we need to talk!
We are seeking an A+ Quality Assurance Lead, to join us in an exciting period of growth and acceleration to lead one of the most critical factors to our success – ensuring regulatory compliance and product quality!
You will lead and execute Quality Assurance related matters with responsibility for all aspects over the product lifecycle, ensuring we have a robust quality system, and a high level of compliance to fulfil our business objectives and support our growth!
This is your chance to make an impact on patients' lives and take an important part in driving MeMed success.
What will you do?
- Lead the oversight of Quality Assurance related matters.
- Establish, maintain and improve Quality Management System to ensure compliance with the applicable regulations, standards and directives.
- Report on the performance of the Quality Management System to senior management for review.
- Management of all Quality activities, including:
- Lead QA activities over the product lifecycle (Product Release, Non-Conformities, Customer Complaints, Corrective and Preventive Actions, Engineering Change Orders, Document Control).
(a) initiating and verifying implementation and effectiveness of corrective actions;
(b) participation in Design Reviews and verification of execution of action items related to quality issues;
(c) approve / reject suppliers and vendors of goods and services
(d) release of products for commercial use
- Lead Supplier Quality activities, including audits of suppliers.
- Continuously improve company’s Quality Management System
- Participate in internal and external quality system audits (ISO9001, ISO13485)
- Certified as CQE/iCQE- an advantage.
- BSc or a higher degree in the area of Biotechnology / Biology / Biochemistry or Engineering – an advantage.
- At least 3 years of experience in leading and executing Quality Assurance activities in a Biotech/Pharma company (according to ISO13485 & GMP).
- Experience with audits of regulatory bodies, root cause investigations, CAPA, ECO and supplier management.
- Analytical and technical skills and experience with supplier audits.
- Excellent English (Verbal and Written).
- Attention to detail, ability to collaborate and get things done in a fast-paced environment.
- Creative and independent problem-solving skills with high professional maturity.
- Outstanding communication skills.
Location & Travel:
MeMed headquarters are based in Haifa, Israel. Some travel will be required.