Required Quality Sys Eng - P4
Yokneam, Israel
ID: 577277
Main Duties:
Member of integrated product team (IPT)- responsible for supporting activities required to ensure quality of the design though compliance with design controls.
Lead proactive design assurance activities facilitating the development and release of high-quality products.
Review and approve product design document- in accordance with design controls standards and companys policies. This includes but is not limited to design verification and design validation activities.
Parenting with R&D- ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards.
Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
Partnering with R&D, RA, Clinic affairs and BU, ensure that pre-release elements of risk management activities are properly conducted and included within the applicable risk management file.
Requirements: Bachelors degree in Life Science, Engineering field or second degree in fields of quality and statistics
Proven experience in quality systems (4- 5 years) and in medical device field (minimum 3 years).
Experience working in an FDA and ISO 13485 regulated environment.
Project management skills, strong communication, problem solving, and analytical skills are required.
Leadership skills without direct authority responsibility
Strong English capabilities.
This position is open to all candidates.