Global Technical Talent
Primary Job Title : Quality Engineer
Alternate Job Titles : Validation Engineer, Quality Assurance Engineer, Medical Device Quality Engineer, Process Validation Engineer, Risk Management Engineer
Location : San Diego, CA
Onsite Flexibility : Onsite
Contract Details
Type : Contract
Duration : 6 months
Extension : Possible
Pay Rate : $45/hr
Shift/Hours : First shift, 8 hours (start between 7 AM – 9 AM)
Job Summary
The
Quality Engineer II
plays a key role in ensuring compliance and reliability within a medical device environment. This role is responsible for
validation activities , including equipment, process, and cleaning validations, as well as risk assessments and quality oversight. Key Responsibilities Provide
Quality leadership
in validation, design transfer, risk management, and specification development. Author and execute
validation protocols and reports
(analytical methods, cleaning, processes, equipment, facilities/utilities, raw materials). Review and approve document change orders, development studies, and change controls. Generate and maintain
process FMEAs
and risk assessments for NCEs and deviations. Support
regulatory submissions
with validation documentation. Lead and collaborate with cross-functional teams on new product introduction (NPI) and sustaining projects. Draft and maintain master validation plans and related departmental procedures. Participate in
Material Review Board (MRB)
and Production Response Team (PRT) meetings. Propose and support
process improvements
using data-driven approaches. Provide
status updates
and escalate issues to management as needed. Required Experience Bachelor’s degree in Science or Engineering. 0–2 years in medical device, biotech, diagnostics, or pharmaceutical environments. Experience in
validation methods and process qualifications . Knowledge of
CDRH, CBER, ISO regulations
(21 CFR Part 820, ISO 13485, ISO 14971). Familiarity with 21 CFR Part 11 and electronic document management systems. Nice-to-Have Experience Validation experience with
custom equipment . Statistical sampling design and risk assessment experience (PFMEA, SPC). Project leadership in cross-functional teams. Required Skills Strong knowledge of
validation and quality processes . Proficiency in
MS Word, Excel, Project . Solid
problem-solving and organizational
skills. Strong cross-functional collaboration and communication. Preferred Skills Hands-on experience with
risk-based validation approaches . Knowledge of acceptance sampling and statistical analysis. Additional Skills Organized and detail-oriented. Ability to manage
multiple projects
concurrently. Excellent written and verbal communication. Physical Demands Ability to sit, stand, walk, kneel, stoop, or crouch as needed. Lift/move up to 40 lbs. Work in environments with exposure to chemicals, mechanical equipment, and moderate noise. Occasional exposure to
blood and biological materials . Benefits Medical, Vision, and Dental Insurance Plans 401(k) Retirement Fund About the Client An
innovative medical technology company
dedicated to empowering healthier lives with science-based solutions. With a focus on
women’s health , the organization provides technologies that detect, diagnose, and treat illnesses earlier — helping millions of people worldwide. About GTT GTT is a
minority-owned staffing firm
and a subsidiary of Chenega Corporation, an Alaska Native-owned company. We proudly serve diverse industries including biotech, healthcare, and technology, connecting professionals with leading career opportunities across the U.S. and Canada.
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Quality Engineer II
plays a key role in ensuring compliance and reliability within a medical device environment. This role is responsible for
validation activities , including equipment, process, and cleaning validations, as well as risk assessments and quality oversight. Key Responsibilities Provide
Quality leadership
in validation, design transfer, risk management, and specification development. Author and execute
validation protocols and reports
(analytical methods, cleaning, processes, equipment, facilities/utilities, raw materials). Review and approve document change orders, development studies, and change controls. Generate and maintain
process FMEAs
and risk assessments for NCEs and deviations. Support
regulatory submissions
with validation documentation. Lead and collaborate with cross-functional teams on new product introduction (NPI) and sustaining projects. Draft and maintain master validation plans and related departmental procedures. Participate in
Material Review Board (MRB)
and Production Response Team (PRT) meetings. Propose and support
process improvements
using data-driven approaches. Provide
status updates
and escalate issues to management as needed. Required Experience Bachelor’s degree in Science or Engineering. 0–2 years in medical device, biotech, diagnostics, or pharmaceutical environments. Experience in
validation methods and process qualifications . Knowledge of
CDRH, CBER, ISO regulations
(21 CFR Part 820, ISO 13485, ISO 14971). Familiarity with 21 CFR Part 11 and electronic document management systems. Nice-to-Have Experience Validation experience with
custom equipment . Statistical sampling design and risk assessment experience (PFMEA, SPC). Project leadership in cross-functional teams. Required Skills Strong knowledge of
validation and quality processes . Proficiency in
MS Word, Excel, Project . Solid
problem-solving and organizational
skills. Strong cross-functional collaboration and communication. Preferred Skills Hands-on experience with
risk-based validation approaches . Knowledge of acceptance sampling and statistical analysis. Additional Skills Organized and detail-oriented. Ability to manage
multiple projects
concurrently. Excellent written and verbal communication. Physical Demands Ability to sit, stand, walk, kneel, stoop, or crouch as needed. Lift/move up to 40 lbs. Work in environments with exposure to chemicals, mechanical equipment, and moderate noise. Occasional exposure to
blood and biological materials . Benefits Medical, Vision, and Dental Insurance Plans 401(k) Retirement Fund About the Client An
innovative medical technology company
dedicated to empowering healthier lives with science-based solutions. With a focus on
women’s health , the organization provides technologies that detect, diagnose, and treat illnesses earlier — helping millions of people worldwide. About GTT GTT is a
minority-owned staffing firm
and a subsidiary of Chenega Corporation, an Alaska Native-owned company. We proudly serve diverse industries including biotech, healthcare, and technology, connecting professionals with leading career opportunities across the U.S. and Canada.
#J-18808-Ljbffr