דרושים בתחום בקרת איכות

Provide guidance and participates in Feasibility, Development, Design Verification, Design Validation, Design Transfer, and Commercialization reviews and activities from a quality and documentation perspective.
Oversees process and product validations to assure all processes comply with company specifications and regulatory requirements. Reviews, develops and maintains all associated documentation. Assists in process and product improvement projects and provides technical input and assistance.
Provides technical support to company engineers and regulatory team for the review & update of Design History and Technical Files.
Develops, evaluates, implements and maintains technical quality assurance documentation and control systems and standards pertaining to materials, techniques, or company products.
Able to interpret drawings and specifications to develop and apply quality test and inspection methods and able to translate into work instructions.
Proficient in knowledge of the quality System Regulation (21 CFR PART 820, including 21CFR806) and ISO 13485 requirements.
Review departmental SOP's and/or policies for regulatory compliance, and quality control.
Participates in CAPA, MRB and ECO processes as required.

Bachelor’s Degree mechanical engineering or equivalent required.

· Experience in writing quality documentation (work instructions, SOPs, risk management etc.) throughout all product phases.
· 6+ years’ experience in Quality Assurance in a regulated medical device manufacturing environment.

A great career opportunity in medical device global leader company which acted under the banner of: “Quality is Our Priority”. Full ownership on final inspection of our products.

A Day in the Life

We offer you a position where Product ATP Specialist inspect all of our finish goods products to ensure compliance with our high quality standards. Their chief goal is to ensure that our products will be deliver to our customers in the highest quality standards.

Must Haves
· Technical knoledgle
· Min 3 years experience with medical devices CM MFG.
· Min 3 years experience in Mfg./Operation plants or facilities.
· Min 3 years in HighTech medical devices company
· Sufficiant level of English.
· PLM system experience as a user.
· QMS experience as a user.


Nice to Haves
· Global corporates experience

· E.S.I Novel ltd’ part of Essence-group, is medical Aesthetics company located in Hertzliya Israeli hi-tech capital. E.S.I Novel design develop & distribute breakthrough innovative state of art professional and home use Medical aesthetics solutions.
· The Company is seeking a Manager of Quality Assurance with experience in the medical device industry and with extensive knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulations (QSRs), International Organization of Standardization (ISO) 13485:2016 Medical Device Directive (MDD) 93/42/EEC, ISO 14971:2007.
· The Quality Assurance Manager will report directly to company General Manager and will work closely within project teams (and in some cases independently) contributing technical leadership/knowledge capabilities.
· This position will contribute to the review of design process, production engineering and production activities. This position will interact with project management, HW and SW teams and other company technical departments and subcontractors on regular bases. R

· Minimum BS/BA in business management or a science discipline (electronic engineering as advantage).
· 5+ years of experience implementing test strategies, process validation and verification in FDA-compliant medical device industry.
· Demonstrated success in a start-up, entrepreneurial work environment.
· Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
· Familiar with EN 60601, Safety requirements for medical electrical systems and ISO 62304, Medical Device Software – Software Life Cycle processes.
· 4 or more years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485 and ISO 14971 standards
· Lead role (administrative or technical) in one or more FDA or other Worldwide medical authority’s submissions for approval of a medical device as advantage.
· Project management skills and proficiency and analysing and interpreting test data.