Design quality engineer

Education and Experience

Ø Bachelor’s Degree in Life Science, Engineering field or second degree in felids of quality and statistics.

Ø Proven experience in Quality systems (minimum 5 years) and in multidisciplinary medical device company (minimum of 2-3 years).

Ø Experience as a Design Quality Engineer, including design control and risk management

Ø In-depth knowledge of software validation  (CSV and SW development lifecycle)

Ø Experience working in an FDA and ISO 13485 regulated environment.

Ø Strong understanding of product lifecycle process.

Ø Project Management skills, strong communication, problem solving, and analytical skills are required.

Ø Leadership skills without direct authority responsibility.

Ø Strong English capabilities – a must.

Ø Self-motivated and proactive.

Ø Ability to analyze data and write technical reports

Ø Proactive approach and ability to work independently.

Ø Knowledge of sterile products and validation requirements for sterilization and shelf life.

Job description and responsibilities:

Ø Assure company compliance to FDA and ISO 13485 Design Control requirements, support product development teams.

Ø Collaborate closely with the development department to ensure product quality.

Ø Lead quality processes & activities for NPI products & projects.

Ø Responsible for supporting activities required to ensure quality of the design through compliance with design controls.

Ø Leads proactive design assurance activities facilitating the development and release of high-quality products.

Ø Review and approve product design documents - in accordance with Design Controls standards and company's policies. This includes but is not limited to design output, verification, and design validation activities.

Ø Partnering with R&D - ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulations and standards.

Ø 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.

Ø Assure compliance of risk management life cycle that covers design, process and usability failure mode and effective analysis.

Ø supports the creation and execution of design transfer activities for both internal and external manufacturing.

Ø Partnering with Engineering, supports the development and execution of process and test method validation activities for newly products.

Ø Support continuous improvement activities to reduce product failure rates.

Ø Train and guide R&D, engineering and involved function to comply with design control requirements.

Ø Review and approved software validation protocols and reports from a quality perspective and according to standards and regulations