MDA Edge
Sr. Software Quality Engineer (Computer Software Validation-CSV)
MDA Edge, Jacksonville, Florida, United States, 32290
Sr. Software Quality Engineer (Computer Software Validation-CSV)
1 month ago Be among the first 25 applicants This range is provided by MDA Edge. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$45.00/hr - $45.00/hr Responsibilities:
Lead
Computer Software Validation (CSV)
project planning activities, including creating and updating
User Requirements Specifications (URS), Software Design Specifications (SDS),
and
Requirements Traceability Matrices (RTM) . Develop, review, and approve software validation documentation. Create and execute qualification protocols, document reports, and review and approve software test scripts and code reviews. Evaluate and approve internal and vendor software packages and test documentation. Prioritize and manage all assigned projects within the software validation department. Implement and support policies, procedures, and processes related to
CSV, Software Development Life Cycle (SDLC) , and software validation for computerized systems. Serve as the
Software Quality Engineering (SQE)
representative in the
Change Control Board (CCB)
to facilitate change validation. Lead
Installation Qualification (IQ)
activities for manufacturing lines. Drive
CSV
improvement initiatives within the manufacturing environment. Promote cross-functional collaboration across teams, sites, and operating companies in CSV. Identify and resolve obstacles impacting business needs. Work closely with
Franchise Quality
to implement and sustain
Quality System
initiatives at the site level. Support compliance efforts by ensuring audit readiness and participating in audits related to CSV. Act as the
Subject Matter Expert (SME)
for CSV, leading investigations, responses, and remediation of CSV audit findings. Qualifications:
Strong knowledge of
FDA
and
European medical device regulations (QSR and ISO) . Expertise in
software validation
requirements for medical device production and
Quality System
software. Proficiency in
GAMP5
and
SDLC
methodologies. Understanding of regulations for
electronic records, electronic signatures, and data integrity . Experience in
change management
with strong technical writing skills. Hands-on experience with
SCADA
and/or
Manufacturing Execution Systems (MES) , with a background in manufacturing/operations. Medical device
process validation
experience (preferred). Experience in
Quality Auditing
and notified body inspections (preferred). Background in
Quality Systems process development, support, integration, or enhancement
(preferred). Experience in
training or coaching
others (preferred). Certification as a
Software Quality Engineer (CSQE)
or
Quality Engineer (CQE)
(preferred). Must-Have Skills:
Minimum of 4 years
of experience in a
regulated environment . 2-4 years
of experience in
medical device regulations . Strong knowledge of
FDA and European medical device regulations (QSR and ISO) . Expertise in
software validation
for medical device production and
Quality System
applications. Working knowledge of
GAMP5 and SDLC . Understanding of
electronic records, electronic signatures, and data integrity regulations . Experience with
change management
and technical writing. Hands-on experience with
SCADA and/or MES
in a
manufacturing/operations
setting. Seniority level
Mid-Senior level Employment type
Full-time Job function
Other Industries
IT Services and IT Consulting Referrals increase your chances of interviewing at MDA Edge by 2x Sign in to set job alerts for Senior Software Quality Engineer roles. #J-18808-Ljbffr
1 month ago Be among the first 25 applicants This range is provided by MDA Edge. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$45.00/hr - $45.00/hr Responsibilities:
Lead
Computer Software Validation (CSV)
project planning activities, including creating and updating
User Requirements Specifications (URS), Software Design Specifications (SDS),
and
Requirements Traceability Matrices (RTM) . Develop, review, and approve software validation documentation. Create and execute qualification protocols, document reports, and review and approve software test scripts and code reviews. Evaluate and approve internal and vendor software packages and test documentation. Prioritize and manage all assigned projects within the software validation department. Implement and support policies, procedures, and processes related to
CSV, Software Development Life Cycle (SDLC) , and software validation for computerized systems. Serve as the
Software Quality Engineering (SQE)
representative in the
Change Control Board (CCB)
to facilitate change validation. Lead
Installation Qualification (IQ)
activities for manufacturing lines. Drive
CSV
improvement initiatives within the manufacturing environment. Promote cross-functional collaboration across teams, sites, and operating companies in CSV. Identify and resolve obstacles impacting business needs. Work closely with
Franchise Quality
to implement and sustain
Quality System
initiatives at the site level. Support compliance efforts by ensuring audit readiness and participating in audits related to CSV. Act as the
Subject Matter Expert (SME)
for CSV, leading investigations, responses, and remediation of CSV audit findings. Qualifications:
Strong knowledge of
FDA
and
European medical device regulations (QSR and ISO) . Expertise in
software validation
requirements for medical device production and
Quality System
software. Proficiency in
GAMP5
and
SDLC
methodologies. Understanding of regulations for
electronic records, electronic signatures, and data integrity . Experience in
change management
with strong technical writing skills. Hands-on experience with
SCADA
and/or
Manufacturing Execution Systems (MES) , with a background in manufacturing/operations. Medical device
process validation
experience (preferred). Experience in
Quality Auditing
and notified body inspections (preferred). Background in
Quality Systems process development, support, integration, or enhancement
(preferred). Experience in
training or coaching
others (preferred). Certification as a
Software Quality Engineer (CSQE)
or
Quality Engineer (CQE)
(preferred). Must-Have Skills:
Minimum of 4 years
of experience in a
regulated environment . 2-4 years
of experience in
medical device regulations . Strong knowledge of
FDA and European medical device regulations (QSR and ISO) . Expertise in
software validation
for medical device production and
Quality System
applications. Working knowledge of
GAMP5 and SDLC . Understanding of
electronic records, electronic signatures, and data integrity regulations . Experience with
change management
and technical writing. Hands-on experience with
SCADA and/or MES
in a
manufacturing/operations
setting. Seniority level
Mid-Senior level Employment type
Full-time Job function
Other Industries
IT Services and IT Consulting Referrals increase your chances of interviewing at MDA Edge by 2x Sign in to set job alerts for Senior Software Quality Engineer roles. #J-18808-Ljbffr