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Job Title: Quality Engineer I
Location: Irvine, CA
Duration: 12 Months contract with possible extension
Job Description:
The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
Job Duties:
Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
Proficient in project management, data analysis, root cause analysis, communication, and risk determination
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
Must Haves:
Bachelor’s degree in Engineering, Biomedical, or STEM field
0-2 years of relevant experience in a regulated industry (FDA environment preferred)
New Grads are highly encouraged to apply
MS Office
Preferred Experience:
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
Contractor
Business Services
$107k-127k (estimate)
07/04/2024
08/01/2024
tech-observer.com
PARAMUS, NJ
200 - 500
2005
AMIT KRISHNATRY
$10M - $50M
Business Services
The job skills required for Quality Engineer include Troubleshooting, Project Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.