Kasmo Global
Job Title:
Quality Engineer II - QMS Focus Location:
Irvine, California Type:
Contract (1+ Year)
Position Summary:
We are seeking experienced
Quality Engineers II
with a strong focus on
Quality Management Systems (QMS)
to support the implementation, maintenance, and continuous improvement of our client's QMS in a regulated environment. This role is critical to ensuring compliance with
ISO 13485 ,
FDA 21 CFR Part 820 , and other relevant standards. Candidates should have experience driving
CAPA ,
NC , and
audit readiness , as well as cross-functional collaboration to drive quality improvements.
Key Responsibilities: Ensure QMS compliance with
ISO 13485 ,
FDA 21 CFR Part 820 , and applicable regulatory requirements. Lead and support
Nonconformance (NC)
and
Corrective and Preventive Action (CAPA)
processes, including timely closure and effectiveness checks. Collaborate with manufacturing, engineering, and supply chain to improve processes and reduce quality risks. Support and participate in
internal audits , and assist during
external regulatory and notified body audits . Track and analyze
quality metrics/KPIs , perform trend analysis, and implement corrective actions. Evaluate and support
change control processes , including quality impact assessments. Conduct
complaint investigations
and support
field action
execution as needed. Apply
risk management principles
(per ISO 14971) across product and process development. Support
validation activities
(IQ/OQ/PQ) for equipment, software, and processes. Use statistical tools (
SPC ,
DOE ,
Gage R&R ) to optimize inspection and sampling strategies. Promote
Human Factors Engineering (HFE)
in design and process development. Deliver training sessions and awareness programs to enhance QMS compliance and quality culture. Required Qualifications:
3-6+ years of experience in
Quality Engineering , preferably in the
medical device
or
regulated industry . Strong understanding of
QMS standards and regulations : ISO 13485, FDA QSR, EU MDR. Hands-on experience with quality tools:
CAPA, FMEA, Root Cause Analysis, 8D, 5 Whys . Familiar with
document control ,
change management , and
validation protocols . Strong communication, problem-solving, and cross-functional collaboration skills. Ability to work independently and manage multiple quality initiatives simultaneously. Preferred Qualifications:
Experience interacting with
regulatory agencies
(FDA, TUV, MoH, etc.). Experience with
eQMS platforms
such as
MasterControl
or
TrackWise . Certifications such as
CQE ,
CQA , or
Six Sigma . Proficient in
data analysis ,
reporting , and common
quality software tools .
Quality Engineer II - QMS Focus Location:
Irvine, California Type:
Contract (1+ Year)
Position Summary:
We are seeking experienced
Quality Engineers II
with a strong focus on
Quality Management Systems (QMS)
to support the implementation, maintenance, and continuous improvement of our client's QMS in a regulated environment. This role is critical to ensuring compliance with
ISO 13485 ,
FDA 21 CFR Part 820 , and other relevant standards. Candidates should have experience driving
CAPA ,
NC , and
audit readiness , as well as cross-functional collaboration to drive quality improvements.
Key Responsibilities: Ensure QMS compliance with
ISO 13485 ,
FDA 21 CFR Part 820 , and applicable regulatory requirements. Lead and support
Nonconformance (NC)
and
Corrective and Preventive Action (CAPA)
processes, including timely closure and effectiveness checks. Collaborate with manufacturing, engineering, and supply chain to improve processes and reduce quality risks. Support and participate in
internal audits , and assist during
external regulatory and notified body audits . Track and analyze
quality metrics/KPIs , perform trend analysis, and implement corrective actions. Evaluate and support
change control processes , including quality impact assessments. Conduct
complaint investigations
and support
field action
execution as needed. Apply
risk management principles
(per ISO 14971) across product and process development. Support
validation activities
(IQ/OQ/PQ) for equipment, software, and processes. Use statistical tools (
SPC ,
DOE ,
Gage R&R ) to optimize inspection and sampling strategies. Promote
Human Factors Engineering (HFE)
in design and process development. Deliver training sessions and awareness programs to enhance QMS compliance and quality culture. Required Qualifications:
3-6+ years of experience in
Quality Engineering , preferably in the
medical device
or
regulated industry . Strong understanding of
QMS standards and regulations : ISO 13485, FDA QSR, EU MDR. Hands-on experience with quality tools:
CAPA, FMEA, Root Cause Analysis, 8D, 5 Whys . Familiar with
document control ,
change management , and
validation protocols . Strong communication, problem-solving, and cross-functional collaboration skills. Ability to work independently and manage multiple quality initiatives simultaneously. Preferred Qualifications:
Experience interacting with
regulatory agencies
(FDA, TUV, MoH, etc.). Experience with
eQMS platforms
such as
MasterControl
or
TrackWise . Certifications such as
CQE ,
CQA , or
Six Sigma . Proficient in
data analysis ,
reporting , and common
quality software tools .