Design Assurance Quality Engineer

Irvine, CA, US • Posted 2 days ago • Updated 2 days ago

Contract W2

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Job Details

Skills

Analytical Skill
Attention To Detail
Auditing
Collaboration
Communication
Computer Aided Design (CAD)
Conflict Resolution

Summary

We are looking for Design Assurance Quality Engineer for our client in Irvine, CA

Job Title: Design Assurance Quality Engineer

Job Location: Irvine, CA

Job Type: Contract

Job Overview:

Pay Range: $51.82hr - $56.82hr

Responsibilities:

Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyze results, and make recommendations
Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.
Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971
Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.
Strong leadership and collaboration with other leaders in project and across the organization
Mentor engineers in understanding of quality systems and strategies within new product development.
Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools.
Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
Train, coach, and guide lower-level employees on more complex procedures
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.

Skills:

Creativity, verbal and written communication skills, analytical and problem-solving ability.
Team player and detail-oriented.
Basic leadership and mentoring skills necessary to provide support and constructive performance feedback.
Ability to read and interpret blueprints, technical drawing, schematics, and computer-generated reports.
Previous experience with computer applications and software related to the engineering field, such as Computer Aided Design (CAD).

Education/Experience:

Bachelor's degree in engineering required.
5-7 years experience required.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10516350
Position Id: CA_DAQE_0319
Posted 2 days ago

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