Infosoft, Inc.
This range is provided by Infosoft, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$63.05/hr - $63.05/hr Job Title:
Sr. Biomedical R&D Quality Engineer Pay Rate:
$50 to $63.05/HR Duration:
6 months Location:
Irvine, CA Shift:
8am to 5pm We are looking for
Sr. Biomedical R&D Quality Engineer This
Sr. Quality Engineer II
will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory. Responsibilities:
Support areas of Quality Assurance,
Design Controls ,
Risk Management , Manufacturing Controls, and
Statistical Techniques
for New Product Development ( NPD ) programs. Investigate complex
manufacturing product quality
and compliance issues reported from the field, analyze results, determine
root cause/probable cause , and initiate and review reports. Coordinate and execute change control activities to support rapid innovation. Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.). Participate in escalation tasks and activities, including Project Risk Assessments (PRA). Support or lead
test method development / validation
activities for Design Verification testing and manufacturing inspections for NPD programs. Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launch of robust products. Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports. Ability to
travel up to 10%
domestically and internationally. What you’ll need (Required Qualifications): Bachelor’s degree in
Engineering
with a minimum of (4) years of experience in either
NPD ,
Quality Engineering ,
R&D , and/or Manufacturing; OR a master’s degree in engineering or Scientific field with internship, senior projects, or thesis experience required. Engineering experience within a highly regulated industry. What else do we look for (Preferred Qualifications): Experience in
medical devices
(cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment is preferred. Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation,
Test Method Development , and Process Validation. Experience with root cause analysis or investigations for Complaints,
NCRs , and/or
CAPAs . New Product Development experience from initial concept to commercialization (Class III preferred). Experience with Risk Management and Design Control. Proven expertise in usage of MS Office Suite including MS Excel, Power Point, and Word. Experience with using Adobe Acrobat. Basic understanding of statistical techniques. Strong problem-solving, organizational, analytical, and critical thinking skills. Self-project management and tracking of deliverables with various participants and stakeholders. Strong communication skills across various cross-functional groups and levels. Seniority level
Mid-Senior level Employment type
Contract Job function
Medical Equipment Manufacturing and Manufacturing
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$63.05/hr - $63.05/hr Job Title:
Sr. Biomedical R&D Quality Engineer Pay Rate:
$50 to $63.05/HR Duration:
6 months Location:
Irvine, CA Shift:
8am to 5pm We are looking for
Sr. Biomedical R&D Quality Engineer This
Sr. Quality Engineer II
will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory. Responsibilities:
Support areas of Quality Assurance,
Design Controls ,
Risk Management , Manufacturing Controls, and
Statistical Techniques
for New Product Development ( NPD ) programs. Investigate complex
manufacturing product quality
and compliance issues reported from the field, analyze results, determine
root cause/probable cause , and initiate and review reports. Coordinate and execute change control activities to support rapid innovation. Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.). Participate in escalation tasks and activities, including Project Risk Assessments (PRA). Support or lead
test method development / validation
activities for Design Verification testing and manufacturing inspections for NPD programs. Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launch of robust products. Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports. Ability to
travel up to 10%
domestically and internationally. What you’ll need (Required Qualifications): Bachelor’s degree in
Engineering
with a minimum of (4) years of experience in either
NPD ,
Quality Engineering ,
R&D , and/or Manufacturing; OR a master’s degree in engineering or Scientific field with internship, senior projects, or thesis experience required. Engineering experience within a highly regulated industry. What else do we look for (Preferred Qualifications): Experience in
medical devices
(cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment is preferred. Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation,
Test Method Development , and Process Validation. Experience with root cause analysis or investigations for Complaints,
NCRs , and/or
CAPAs . New Product Development experience from initial concept to commercialization (Class III preferred). Experience with Risk Management and Design Control. Proven expertise in usage of MS Office Suite including MS Excel, Power Point, and Word. Experience with using Adobe Acrobat. Basic understanding of statistical techniques. Strong problem-solving, organizational, analytical, and critical thinking skills. Self-project management and tracking of deliverables with various participants and stakeholders. Strong communication skills across various cross-functional groups and levels. Seniority level
Mid-Senior level Employment type
Contract Job function
Medical Equipment Manufacturing and Manufacturing
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