... Engineer to lead Computer Software Validation (CSV) projects. The role involves managing software ... SME) for CSV, leading investigations, responses, and remediation of site-specific CSV audit ...
... Engineer to lead Computer Software Validation (CSV) projects. The role involves managing software ... SME) for CSV, leading investigations, responses, and remediation of site-specific CSV audit ...
Senior Relativity SME
Miami, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Quick apply
Senior Relativity SME
Miami, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Senior Relativity SME
Miami, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Senior Relativity SME
Miami, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Senior Relativity SME
Tampa, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Quick apply
Senior Relativity SME
Tampa, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
IT Architect
Eglin Air Force Base, FL · On-site
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
IT Architect
Eglin Air Force Base, FL · On-site
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
Senior Relativity SME
Tampa, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Senior Relativity SME
Tampa, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Senior Specialist, Software Engineering 1
Melbourne, FL · On-site
$97K - $180K/yr
Working with technical Leads (TL) and Subject Matter Experts (SME) to design and implement new ... Bachelor's degree in software engineering, Computer Science, Computer Engineering, or related STEM ...
Senior Specialist, Software Engineering 1
Melbourne, FL · On-site
$97K - $180K/yr
Working with technical Leads (TL) and Subject Matter Experts (SME) to design and implement new ... Bachelor's degree in software engineering, Computer Science, Computer Engineering, or related STEM ...
Senior Specialist, Software Engineering 1
Melbourne, FL · On-site
$97K - $180K/yr
Working with technicalLeads (TL) and Subject MatterExperts (SME) to design and implement new ... Bachelor's degree in software engineering, Computer Science, Computer Engineering, or related STEM ...
Senior Specialist, Software Engineering 1
Melbourne, FL · On-site
$97K - $180K/yr
Working with technicalLeads (TL) and Subject MatterExperts (SME) to design and implement new ... Bachelor's degree in software engineering, Computer Science, Computer Engineering, or related STEM ...
IT Architect
Eglin Air Force Base, FL · On-site
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
IT Architect
Eglin Air Force Base, FL · On-site
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
IT Architect
Eglin Air Force Base, FL · On-site
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
IT Architect
Eglin Air Force Base, FL · On-site
... software platforms in multi-site environments. * Demonstrated ability to perform architecture-level responsibilities as a Senior Engineer, Lead Engineer, SME, Architect, or equivalent. A formal ...
Relativity SME with Security Clearance
Miami, FL · On-site
$139K - $189K/yr
Relativity SME Miami, FL / Remote / Hybrid / Tampa, FL eDiscovery / Full Time Hybrid / Hybrid apply ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Relativity SME with Security Clearance
Miami, FL · On-site
$139K - $189K/yr
Relativity SME Miami, FL / Remote / Hybrid / Tampa, FL eDiscovery / Full Time Hybrid / Hybrid apply ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Military Analyst (SME)
Orlando, FL · On-site
$80 - $100/hr
Participate in various materiel developer/combat developer events as medical training requirements ... software test and evaluation activities and experiments from concept refinement through system ...
Military Analyst (SME)
Orlando, FL · On-site
$80 - $100/hr
Participate in various materiel developer/combat developer events as medical training requirements ... software test and evaluation activities and experiments from concept refinement through system ...
Military Analyst (SME)
Orlando, FL · On-site
Participate in various materiel developer/combat developer events as medical training requirements ... software test and evaluation activities and experiments from concept refinement through system ...
Military Analyst (SME)
Orlando, FL · On-site
Participate in various materiel developer/combat developer events as medical training requirements ... software test and evaluation activities and experiments from concept refinement through system ...
Military Analyst (SME)
Orlando, FL · On-site
Participate in various materiel developer/combat developer events as medical training requirements ... software test and evaluation activities and experiments from concept refinement through system ...
Military Analyst (SME)
Orlando, FL · On-site
Participate in various materiel developer/combat developer events as medical training requirements ... software test and evaluation activities and experiments from concept refinement through system ...
Military Analyst (SME)
Orlando, FL · On-site
Participate in various materiel developer/combat developer events as medical training requirements ... software test and evaluation activities and experiments from concept refinement through system ...
Military Analyst (SME)
Orlando, FL · On-site
Participate in various materiel developer/combat developer events as medical training requirements ... software test and evaluation activities and experiments from concept refinement through system ...
Senior Relativity SME with Security Clearance
Miami, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Senior Relativity SME with Security Clearance
Miami, FL · On-site
$179K - $258K/yr
Senior Relativity SME Employment Type: Full-Time, Experienced Department: eDiscovery CGS is seeking ... software engineers at Relativity - Perform Relativity demos, conduct training, and create user ...
Software Architect
Belle Isle, FL · On-site
They are a hands-on technologist who leads by example and coaches engineers in modern, AI-augmented ... expert (SME) in several technologies critical to the organization and contribute to setting ...
Software Architect
Belle Isle, FL · On-site
They are a hands-on technologist who leads by example and coaches engineers in modern, AI-augmented ... expert (SME) in several technologies critical to the organization and contribute to setting ...
Digital S/W Engineer Sr Mgr - Vice President
Jacksonville, FL · On-site
$150 - $200/hr
Design, implement, and deploy software components and solve difficult problems generating positive ... Lead resources and serve as a functional SME across the company through advanced knowledge of ...
Digital S/W Engineer Sr Mgr - Vice President
Jacksonville, FL · On-site
$150 - $200/hr
Design, implement, and deploy software components and solve difficult problems generating positive ... Lead resources and serve as a functional SME across the company through advanced knowledge of ...
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Full-time
Re-posted 14 days ago
Job description
MDAEdge is a company focused on software quality in the medical device sector, and they are seeking a Senior Software Quality Engineer to lead Computer Software Validation (CSV) projects. The role involves managing software validation documentation, supporting compliance efforts, and promoting cross-functional collaboration within the organization.
Responsibilities:
• Lead Computer Software Validation (CSV) project planning activities, including the creation and updates of 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 different teams, sites, and operating companies in the area of CSV.
• Identify and resolve obstacles that impact 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 internal and external audits related to CSV.
• Act as the Subject Matter Expert (SME) for CSV, leading investigations, responses, and remediation of site-specific CSV audit findings.
Qualifications:
Required:
• Strong working knowledge of FDA and European medical device regulations (QSR and ISO).
• Expertise in software validation requirements for both medical device production and Quality System software.
• Proficiency in GAMP5 and SDLC methodologies.
• In-depth 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.
• 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.
Preferred:
• Medical device process validation experience.
• Experience in Quality Auditing and notified body inspections.
• Background in Quality Systems process development, support, integration, or enhancement.
• Experience in training or coaching others.
• Certification as a Software Quality Engineer (CSQE) or Quality Engineer (CQE).
Company:
The world doesn't have a talent shortage. It has a talent alignment problem. MDA Edge exists to fix that. Founded in , the company is headquartered in Sheridan, WY, US, , with a team of 51-200 employees. The company is currently Growth Stage.
About MDA Edge
Sourced by ZipRecruiter
Industry
Custom software development services
Company size
51 - 200 Employees
Headquarters location
Los Altos, CA, US