In this role, you will be responsible to handle raw materials acceptance activities, NCM reports related to raw materials, write and update procedures and forms related to incoming inspection.
Essential Duties and Responsibilities
Responsible for raw materials acceptance activities in ERP/SAP, including approval of acceptance records generated by incoming inspectors and issuance of Certificate of Compliance for approved raw material.
Responsible to verify that all acceptance test results follow GMP and GDP guidelines
Responsible for handling of all related incoming inspection non-conforming materials (NCM), including performing root cause analysis, generate corrective actions and leading MRB meetings to determine the materials disposition.
Responsible to write Special inspection /Rework instruction related to incoming inspection process
Responsible to write and update incoming inspection Forms and procedures
Responsible for the approval of all graphic and label related raw material.
Responsible for the approval of Line clearance performed by quality inspectors
Education
Education- Technical/ Practical Eng.
At least 2 years of relevant experience in Quality in the Medical Device/pharma industry
Courses related to Medical Device regulation- an advantage
Knowledge with ERP/ SAP- an advantage
Work Experience
At least 2 years of relevant experience in Quality in the Medical Device/pharma industry
Preferred Knowledge, Skills and Abilities
Ability to work under pressure
Good interrelation skills
Technical ability- ability to read technical drawings
Creativity
High Learning ability
Organized
Ability to prioritize
Excel -basic knowledge and experience.
Written and verbal communication skills: Hebrew- Mother tongue . English- Good
Physical Requirements
Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.
Additional Requirements
Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
Must maintain the ability to work well with others in a variety of situations
Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
Effectively communicate and interface with various levels internally and with customers