The QA Engineer will report directly to the Director of QA/RA and will be part of QA company team.
This role will work closely with the production, engineering and QC teams.
QA Engineer will assist QA/RA Director in identifying and implementing quality system improvements, specifically for elements related to product quality. QA Engineer will be part of batch release team.
Primary responsibilities will include:
- Promote Good Manufacturing Practices.
- Help to establish control methods and procedures to assure quality of manufactured products.
- Assures compliance to in-house and external specifications and standards.
- Maintain quality assurance objectives.
- Approval of incoming inspections and batch release.
- Writes, review and approval of company document's, specifications, drawing and procedures
- Performs other assignments as required by management
- Contributes to process improvements.
- Work closely with production and logistics teams, interfaces with manufacturing in identifying and correcting quality issues for new and existing product lines.
- Supports QC team with technical input on inspection documentation and with the Material Review Board (MRB). Perform corrective and preventive actions, deviations and change orders.
Good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements.
Excellent writing skills with ability to write quality assurance reports and detailed procedures.
Good presentation skills.
Good interpersonal skills to interact with all levels of the company.
Ethical, truthful, sincere, honest and discreet personality.Collaboration, teamwork orientation.
Education / Experience / Skills:
A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, life-science, medicine, pharmacy, engineering or another relevant discipline.
Knowledge in the field of medical devices/pharmaceuticals and or life- science and at least two (2) years of professional experience in QMS of medical devices or at least 2 years of professional experience in QMS relating to medical devices.
Proficiency in MS-Office and ERP systems
Able to communicate at all organizational levels.
Must have excellent reading, writing and communication skills in English and Hebrew.
Good communication skills
Excellent reporting, teamwork, and time management skills
Ability to learn quickly, analyze problems, work independently and organize and execute multiple work tasks
Ability to read and interpret engineering drawings, product specifications, procedures and standardsExcellent written, oral communication and technical report writing skills.