Principle Quality Engineer - W2Only

Job Title - Principle Quality Engineer

Job Location - Irvine, California,

Job Description -

Ensures product development activities are conducted in accordance with FDA, QSR, ISO 13485 and internal Quality System requirements.

Nice to Have:

Experience with exploratory, early stage in-human clinical trials.

Self-motivated, driven and committed to a team approach

Strong interpersonal, organizational and project management skills

Strong oral, presentation and technical writing skills.

Ability to dissect, condense, and disseminate information appropriately to key stakeholders.

Technical Key Points:

Experience with Risk Management for medical devices.

Experience with electrophysiology/electrical/electromechanical medical device.

Experience with Regulations for electromechanical medical devices.

Responsibilities may include the following and other duties may be assigned.

Collaborates with cross OU to harmonize the design quality requirements/deliverables/procedures and implement to the program.

Experienced in the areas of electrophysiology/electrical/electromechanical engineering design medical device / regulation

Develops, modifies, applies and maintains quality standards and protocol for verification and validation during design/development process.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Advices and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

Create and maintain the risk register on a developing product and communicate to the stakeholders.

Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

May specialize in the areas of electrophysiology, electrical engineering design, incoming material, protocols, performance evaluation and reliability, research and development as they apply to product or process quality.