Design Quality Engineer

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

Lead quality processes & activities for NPI products & projects.

Main Duties:

·        Member of integrated product team %28IPT%29 – responsible for supporting activities required to ensure quality of the design through compliance with design controls.

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

·        Review and approve product design documents – in accordance with Design Controls standards and company%27s policies. This includes but is not limited to design verification and design validation activities. 

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

·        Supports audits and compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are met.

·         Partnering with R&D and Quality assurance, ensures that pre-release elements of risk management activities are properly conducted and included within the applicable risk management files.

·        Partnering with R&D, Operations and Purchasing ensures that designs are properly transferred to internal manufacturing or external suppliers align with SOPs. supports the creation and execution of design transfer activities for both internal and external manufacturing.

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

·        Support continuous improvement activities to reduce product failure rates.

·        Review and approval of DMR and DHR for NPI and Change requests. 

·        Qualified for QA Eng. activities. 

REQUIREMENTS

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

·        Proven experience in Quality systems %28minimum 4 years%29 and in medical device field %28minimum of 2 years%29.

·        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 – a must