Global Technical Talent
Senior Software Quality Engineer
Global Technical Talent, Pleasanton, California, United States, 94566
Overview
Primary Job Title:
Senior Software Quality Engineer Alternate/Related Job Titles: Software Validation Engineer Quality Systems Engineer Software Verification & Validation Engineer Risk & Compliance Quality Engineer Location:
Pleasanton, CA Onsite Flexibility:
Onsite Contract Details: Position Type:
Contract Contract Duration:
12 months Start:
As Soon As Possible (target 11/03/2025) Pay Rate:
$56.04 per hour Shift & Schedule: Shift:
8:00 AM – 5:00 PM (Pacific Time) Schedule:
Monday – Friday Hours per Week:
40
Job Summary
The
Senior Software Quality Engineer
is responsible for executing and maintaining
software quality engineering methodologies
while providing
risk assessment
and
regulatory compliance support
for software systems utilized across the division. This role ensures that all software products and processes meet
FDA ,
ISO 13485 , and
IEC 62304
standards. The ideal candidate will bring a strong background in
software verification and validation (V&V) ,
risk controls , and
traceability matrices
for medical device or healthcare software systems.
Key Responsibilities
Collaborate with
Design and Test Engineering
to complete system/software requirements and support verification and validation processes. Review and approve
software validation protocols
traceable to system and software requirements. Participate in and guide meetings related to
software events, defects, and anomaly investigations . Drive the completion and maintenance of
software-related risk analyses . Design and implement
product and process improvement methodologies
(e.g., Six Sigma, Lean Manufacturing). Apply structured
problem-solving methodologies
to identify, prioritize, and resolve software quality issues. Conduct
software scoping and 21 CFR Part 11 audits
for compliance. Support company initiatives related to
Quality Management Systems (QMS) ,
Environmental Management Systems (EMS) , and other regulatory frameworks. Ensure compliance with
FDA regulations ,
ISO 13485 , and
IEC 62304
standards, as well as internal operating procedures. Maintain cooperative communication with internal teams, customers, contractors, and vendors. Perform other related duties and responsibilities as assigned.
Experience & Qualifications
Bachelor’s degree in
Engineering ,
Computer Science , or a related technical field (or equivalent experience). Minimum
5 years of experience
in
Quality Engineering
within the medical device or in vitro diagnostics industry. Detailed knowledge of
FDA QSR ,
IEC 62304 , and
ISO 13485 . Strong computer skills, including
data analysis
and
technical report writing . Prior experience working in a
regulated environment
(medical device or IVD). Excellent written and verbal communication skills, with the ability to interact effectively across all organizational levels. Strong
organizational and time management skills
with keen attention to detail. Ability to manage multiple priorities and meet tight deadlines in a dynamic environment. Must maintain
regular and predictable attendance .
Nice-to-Have Experience
ASQ CSQE certification
preferred. Experience working in a
cross-functional enterprise environment . Familiarity with
Six Sigma ,
Lean principles , or
CAPA methodologies . Experience with
software traceability ,
validation documentation , and
risk management tools .
Required & Preferred Skills
Software Verification & Validation (V&V) Risk Management & Traceability Quality Systems & FDA Regulatory Compliance ISO 13485 and IEC 62304 Expertise Root Cause Analysis & CAPA 21 CFR Part 11 Audit Knowledge Six Sigma & Lean Methodologies Cross-Functional Communication
Additional Skills
Data Analysis & Report Writing QMS and EMS Compliance Risk Analysis Documentation Project Coordination in Matrixed Teams
Benefits
Medical, Vision, and Dental Insurance Plans 401k Retirement Fund
About the Client
Global Healthcare Innovator
— A leading healthcare company dedicated to improving lives worldwide. The organization’s portfolio includes medical devices, diagnostics, nutrition products, and branded generics. Committed to developing
groundbreaking technologies
that address global healthcare challenges, it empowers people to live healthier, more fulfilling lives. Join the team to: Work on
cutting-edge projects Contribute to
global healthcare advancements Experience diverse cultures and professional growth Build a rewarding career with a company that cares
About GTT
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity! Job Number:
25-27414
#J-18808-Ljbffr
Primary Job Title:
Senior Software Quality Engineer Alternate/Related Job Titles: Software Validation Engineer Quality Systems Engineer Software Verification & Validation Engineer Risk & Compliance Quality Engineer Location:
Pleasanton, CA Onsite Flexibility:
Onsite Contract Details: Position Type:
Contract Contract Duration:
12 months Start:
As Soon As Possible (target 11/03/2025) Pay Rate:
$56.04 per hour Shift & Schedule: Shift:
8:00 AM – 5:00 PM (Pacific Time) Schedule:
Monday – Friday Hours per Week:
40
Job Summary
The
Senior Software Quality Engineer
is responsible for executing and maintaining
software quality engineering methodologies
while providing
risk assessment
and
regulatory compliance support
for software systems utilized across the division. This role ensures that all software products and processes meet
FDA ,
ISO 13485 , and
IEC 62304
standards. The ideal candidate will bring a strong background in
software verification and validation (V&V) ,
risk controls , and
traceability matrices
for medical device or healthcare software systems.
Key Responsibilities
Collaborate with
Design and Test Engineering
to complete system/software requirements and support verification and validation processes. Review and approve
software validation protocols
traceable to system and software requirements. Participate in and guide meetings related to
software events, defects, and anomaly investigations . Drive the completion and maintenance of
software-related risk analyses . Design and implement
product and process improvement methodologies
(e.g., Six Sigma, Lean Manufacturing). Apply structured
problem-solving methodologies
to identify, prioritize, and resolve software quality issues. Conduct
software scoping and 21 CFR Part 11 audits
for compliance. Support company initiatives related to
Quality Management Systems (QMS) ,
Environmental Management Systems (EMS) , and other regulatory frameworks. Ensure compliance with
FDA regulations ,
ISO 13485 , and
IEC 62304
standards, as well as internal operating procedures. Maintain cooperative communication with internal teams, customers, contractors, and vendors. Perform other related duties and responsibilities as assigned.
Experience & Qualifications
Bachelor’s degree in
Engineering ,
Computer Science , or a related technical field (or equivalent experience). Minimum
5 years of experience
in
Quality Engineering
within the medical device or in vitro diagnostics industry. Detailed knowledge of
FDA QSR ,
IEC 62304 , and
ISO 13485 . Strong computer skills, including
data analysis
and
technical report writing . Prior experience working in a
regulated environment
(medical device or IVD). Excellent written and verbal communication skills, with the ability to interact effectively across all organizational levels. Strong
organizational and time management skills
with keen attention to detail. Ability to manage multiple priorities and meet tight deadlines in a dynamic environment. Must maintain
regular and predictable attendance .
Nice-to-Have Experience
ASQ CSQE certification
preferred. Experience working in a
cross-functional enterprise environment . Familiarity with
Six Sigma ,
Lean principles , or
CAPA methodologies . Experience with
software traceability ,
validation documentation , and
risk management tools .
Required & Preferred Skills
Software Verification & Validation (V&V) Risk Management & Traceability Quality Systems & FDA Regulatory Compliance ISO 13485 and IEC 62304 Expertise Root Cause Analysis & CAPA 21 CFR Part 11 Audit Knowledge Six Sigma & Lean Methodologies Cross-Functional Communication
Additional Skills
Data Analysis & Report Writing QMS and EMS Compliance Risk Analysis Documentation Project Coordination in Matrixed Teams
Benefits
Medical, Vision, and Dental Insurance Plans 401k Retirement Fund
About the Client
Global Healthcare Innovator
— A leading healthcare company dedicated to improving lives worldwide. The organization’s portfolio includes medical devices, diagnostics, nutrition products, and branded generics. Committed to developing
groundbreaking technologies
that address global healthcare challenges, it empowers people to live healthier, more fulfilling lives. Join the team to: Work on
cutting-edge projects Contribute to
global healthcare advancements Experience diverse cultures and professional growth Build a rewarding career with a company that cares
About GTT
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity! Job Number:
25-27414
#J-18808-Ljbffr