For a hi-tech company developing medical devices, with offices in the north Sharon.
Collaborates with global Operations, QA, Engineering and Manufacturing functions to ensure quality standards are in place.
Leads manufacturing transfer quality engineering activities.
Leads and contributes to manufacturing process and process controls improvement initiatives.
Supports day to day manufacturing activities performed at CMs.
Participates in and influences in release product changes core teams.
Takes an active role in leading, reviewing and approving design and manufacturing changes.
Performs and reviews change impact assessments to manufacturing and post market characteristics.
Leads product quality investigations in support of CAPA, complaints and Non-conforming material processes.
Collect, analyze and interpret statistical data, performs analyses and provide reports as required.
Leads Quality Assurance and product quality improvements cross functional initiatives
Bachelor degree in mechanical or similar engineering disiplines .
5+ Years of Quality Assurance experience in Medical device companies or other highly regulated industries.
Strong knowledge of applicable standards and regulations standards
Vast experience with design changes, change impact asseesment and design transfer activities.
Strong understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations.
Experience in application of risk management techniques (FMEA, FTA) in supporting of design, production and post production activities
Strong understanding of product lifecycle process
Ability to work effectively in a team environment with a diverse group of people.
Fluent in English and Hebrew
:Nice to Haves
Certified Quality Engineer (CQE) or other similar Quality/reilibility certifications
Six Sigma certification
Experience with medical device sterilization and reprocessing standards.
Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline.
EUMDR and MDSAP knowledge/experience
Biotech/medical, High Tech
Medium (50 - 150)