Boston Scientific DQA Engineer 

Israel, North District, Yokneam Ilit 

631817070

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 company’s 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.

Required Qualifications:

• 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.