Quality Assurance Expert - 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 Expert, 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 oversight of 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?
- Manage and continuously improve company’s Quality Management System to comply with the applicable regulations and standards.
- Manage QA activities over the product lifecycle (Product Release, Non-Conformities, Customer Complaints, Corrective and Preventive Actions, Design Controls, Engineering Change Orders, Training, Document Control).
- Manage Supplier Quality activities, including audits of suppliers.
- Serve as the delegated Quality Management Representative.
- Manage internal and external quality system audits (ISO9001, ISO13485).
- Mentor, train and lead oversight of QA related matters.
Requirements:
- B.Sc or a higher degree in the area of Biotechnology / Biology / Biochemistry or Engineering
- Minimum of 8 years' experience in leading and executing Quality Assurance activities in a fast-paced Biotech/Pharma environment. Managing a team- an advantage
- Vast experience with audits of regulatory bodies, and root cause investigations
- Exceptional analytical and technical skills and experience with supplier audits
- Experience in IVD – an advantage
- Experience with MDSAP – an advantage
- Excellent English (Verbal and Written)
- Accountability to make things happen and drive for excellent execution
- Exceptional project management skills, 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.
