Manufacturing Validation Engineer
ISRAEL
DESCRIPTION:
The Validation Engineer provides customer and factory-facing quality support for contract manufacturing of medical device components. The position includes managing the interface between Resonetics and customers’ supplier quality organization, assisting with transition and sustaining of laser micromanufacturing processes, and support for supplier quality management.
This position uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, reducing dependence on inspection, ISO 13485 compliance.
Location: Or Akiva, Israel
RESPONSIBILITIES:
- Writing Protocols for Validation of Medical Equipment and Processes
- Implementation of ISO 13485 quality standards and regulations.
- Interfaces with all internal and external parties including customers and suppliers
- Maintaining company documentation, such as drafting and distribution of specifications, SOPs, work instructions and inspection procedures.
- Handling of customer complaints and NCR including root cause analysis and CAPA.
- Perform quality training of employees.
- Responsible for implementing calibration and preventive maintenance.
- Report to QA&RA Director.
REQURIED QUALIFICATIONS:
- Quality Engineer / Industrial engineer or other relevant degree specializing in quality.
- Minimum 2 years’ experience in Writing Protocols for Validation of Medical Equipment and Processes.
- Good investigative and problem-solving skills with excellent attention to details.
- Good oral communication skills, in Hebrew and in English.
- Excellent writing skills in Hebrew and in English.
- Proficient in MS Office, Priority-an advantage.
- Able to work independently and as part of a team.
- Knowledge and experience with ISO 13485.
Location: Or Akiva, Israel