Quality Engineer

30 Jun 2024

Vacancy expired!

Ledgent Technology is looking for a Quality Engineer with the below background.

Title: Quality EngineerFulltime/ Direct HireLocation: San Jose, CA

The Quality Engineer works as an integral part of the medical engineering team responsible for designing and manufacturing high-quality medical products. The QE is a voice of quality in new product development as well as a driving force to define and resolve customer quality issues and other day-to-day production issues. Responsible to provide Quality Engineering support across New Product Integration and Sustaining business lines as detailed below:

Essential Functions: Monitor process metrics to evaluate process performance, define control points, and work with engineering, and manufacturing to ensure that minimum expectations are met. Support process validation studies for special processes to improve medical quality assurance methodology. Support development of Product Validation Plans, IQ/OQ/PQ protocols, and Test Measurement Validations. Resolve any special quality, test, and certification requirements in cooperation with engineering and assure overall agreement between Medical and customer drawings and specifications. Draft and execute the design of experiments (DOE) and capability studies. Work as a part of a core team with Development and Manufacturing Engineering as required in new product introduction. Contribute to all new product deliverables, including Design and Process FMEA, Control Plans, etc. Create Quality Inspection Plans for components and assembly. Work to affect the Cost of Quality improvement projects. Work with Manufacturing Engineering in the day-to-day identification & resolution of production issues. Drive to resolve product return and customer complaint issues. Support the new product development processes to assure the product meets customer requirements. Support the verification system at Medical for new and existing products. Support 1st Article inspection program, process capability studies, and inspection audit to verify quality levels for problem P/Ns. Develop standard quality inspection procedures and methods. Promote compliance to company procedures.

Qualifications BS degree in science, engineering, or manufacturing. 2+ years of experience in Quality Engineering Demonstrated understanding of quality concepts, practices and procedures. Strong interpersonal skills are required. Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare statistical quality control data, and develop statistically designed experiments. Knowledge of FDA 21 CFR Part 820 and ISO 9001 or 13485. Ability to travel as necessary.

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

  • ID: #43709975
  • State: California Sanjose 95131 Sanjose USA
  • City: Sanjose
  • Salary: US95000 - US110000 per annum
  • Job type: Permanent
  • Showed: 2022-06-30
  • Deadline: 2022-08-28
  • Category: Et cetera