Principle Quality Engineer - Medical Device Job at Planet Pharma, Irvine, CA

OFRReENsbW1DcCs1ZVlNZ2dBU2NnaTA5NkE9PQ==
  • Planet Pharma
  • Irvine, CA

Job Description

Hourly Pay - Market Rate

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

Top 3 technical skills that are required for the role:

  1. Experience with Risk Management for medical devices.
  2. Experience with electrophysiology/electrical/electromechanical medical device.
  3. 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.

Bachelor in Engineering

Years’ Experience Required:

5-12 yrs

Job Tags

Hourly pay,

Similar Jobs

Opportunity Education

High School Science Teacher Job at Opportunity Education

 ...Science Teacher About Quest Forward High School Quest Forward High School, a cutting-edge private school in West Central Omaha, is looking to add a Science...  ...regular coaching from the schools Associate Director, Teaching & Learning, the Science Teacher will be... 

Comprehensive Community Action Program

Quality Improvement Nurse Job at Comprehensive Community Action Program

 ...poverty as well as social and cultural barriers, through advocacy, education, and access to high quality health and human services. Job Summary The Quality Improvement Nurse, guided by the Director of Quality Assurance, Risk Management and Compliance, supports... 

Robert Half

Senior Accountant Job at Robert Half

 ...The ideal candidate will have a strong full-cycle GL accounting experience. Qualifications ~ Bachelor's degree in accounting, Finance, or Economics or equivalent experience ~5+ Years of Corporate Accounting medium and/or large companies Responsibilities... 

Medical Services of America

Certified Nursing Assistant - Hospice Job at Medical Services of America

 ...Medi Home Hospice , a proud member of the Medical Services of America, Inc. family, currently seeks an experienced Full-Time Hospice Aides...  ...Glen Allen, VA. As a member of a multidisciplinary team, the CNA works under the general direction of the Registered Nurse/Case... 

Ultimate Staffing

Welder - 2nd shift -730 Job at Ultimate Staffing

 ...welding on a variety of sheet metal components, ensuring that all fabricated parts meet blueprint specifications and quality standards. The...  ...parts Perform TIG welding on aluminum and stainless-steel components Read and interpret blueprints, drawings, and work orders...