Quality Assurance Expert - ISR
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Job Description
Quality Assurance Expert ISR
Who are we
We are here to improve the lives of patients through innovative technologies. Were a rapidly growing interdisciplinary team of professionals passionate about developing disruptive technologies that use the bodys 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.memed.
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 companys Quality Management System to comply with the applicable regulations and standards.
- Manage QA activities over the product lifecycle (Product Release NonConformities 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 fastpaced 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
- Exceptional project management skills attention to detail ability to collaborate and get things done in a fastpaced environment
- Creative and independent problemsolving skills with high professional maturity
- Outstanding communication skills
Location & Travel:
MeMed headquarters are based in Haifa Israel. Some travel will be required.
Employment Type
Full Time
