Principal Quality Engineer Medical Device

Job Title: Principal Quality Engineer – Medical Device

Job Location: Irvine, California (Fully Onsite)

Type: W2 Contract

Job Description:

Ensures product development activities are conducted by 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 skills that are required for the role:

• Experience with Risk Management for medical devices.

• Experience with electrophysiology/electrical/electromechanical medical devices.

• Experience with Regulations for electromechanical medical devices.

Education Required: Bachelor's in Engineering, Years’ Experience Required: 5-12 yrs

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

Collaborates with cross-OU to harmonize the design quality requirements/deliverables/procedures and implements them in 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 the design/development process.

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

Advise and implement 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 it 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.

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

Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.