דרושים בתחום בקרת / אבטחת איכות

Leading supplier quality engineering activities supporting production and medical device release processes. This positions Partners with QA, Engineering, Supply Chain and supplier’s functions to ensure quality and compliance of manufactured products.

A Day in the Life
Responsibilities may include the following and other duties may be assigned

· Supports contract manufacturers and supplier quality activities and monitors production and compliance key process indicators.
· Performs supplier audits and monitors findings closure.
· Handles Supplier Corrective Action with supplier and monitors execution.
· Supports new product introduction activities including process, equipment, SW and environment validations, production risk management, control plans component qualification and staff training.
· Utilizes advance statistical tools and practices to analyze and improve production and product performance.
· Represents supplier quality in internal and external audits.
· Participates in Material Review Boards and communicates back to supplier.
· Supports incoming inspection specification development.
· Provide onsite QA support to contract manufacturers.
· Communicates Engineering Changes Notices (ECN) to suppliers and monitors implementation

Must Haves
· Bachelor degree in mechanical, electrical or similar engineering disiplines .
· 5+ Years of Quality Assurance experience in Medical device or other regulated industry.
· Understyanding of of applicable standards and regulations such as ISO 13485:2016 and 21 CFR 820.
· 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 in supporting of design, production and post production activities.
Strong knowledge in CAPA, NCMR, RMA, Labeling, Rework and Batch release processes.
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

Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline.
Supplier Quality Engineering experience.

· Working knowledge of process improvement skills including Six Sigma, Lean Sigma.