Sr. Software Quality Engineer
2 weeks ago
- 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.
- ct as the Subject Matter Expert (SME) for CSV, leading investigations, responses, and remediation of site-specific CSV audit findings.
Qualifications:
- 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.
- 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.
-
Quality Engineer
2 weeks ago
Jacksonville, FL, United States CData Software Full timeWorking knowledge of FDA and European medical device regulations (QSR and ISO) is required.? Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System is required.? Working knowledge of GAMP5 and SDLC is required.? Working knowledge of regulations for...
-
Sr. Software Simulation Engineer
3 days ago
Jacksonville, FL, United States Kavaliro Full timeKavaliro is seeking a Sr. Software Engineer with an understanding of motion simulators for a local Jacksonville client. This position will be onsite Monday - Friday, with hybrid opportunities in the future. You will lead a diverse skill set team working with simulation development professionals while responsible for the full Software Development Life Cycle...
-
Sr. Software Simulation Engineer
6 days ago
Jacksonville, FL, United States Kavaliro Full timeKavaliro is seeking a Sr. Software Engineer with an understanding of motion simulators for a local Jacksonville client. This position will be onsite Monday - Friday, with hybrid opportunities in the future. You will lead a diverse skill set team working with simulation development professionals while responsible for the full Software Development Life Cycle...
-
Software Project Engineer Business Analyst
2 weeks ago
Jacksonville, FL, United States Appx Software Full timeJob Description Job Description We are seeking a dynamic and detail-oriented professional to serve as a critical link between our customers and our development team. This individual will ensure our clients' needs are met, define project requirements, and oversee the design and development of software solutions. Acting as a business analyst, a project...
-
Software Project Engineer Business Analyst
1 week ago
Jacksonville, FL, United States Appx Software Full timeJob Description Job Description We are seeking a dynamic and detail-oriented professional to serve as a critical link between our customers and our development team. This individual will ensure our clients' needs are met, define project requirements, and oversee the design and development of software solutions. Acting as a business analyst, a project...
-
Jacksonville, FL, United States Appx Software Full timeJob Description Job Description We are seeking a dynamic and detail-oriented professional to serve as a critical link between our customers and our development team. This individual will ensure our clients' needs are met, define project requirements, and oversee the design and development of software solutions. Acting as a business analyst, a project...
-
Software Project Engineer Business Analyst
6 days ago
Jacksonville, FL, United States Appx Software Full timeJob Description Job Description We are seeking a dynamic and detail-oriented professional to serve as a critical link between our customers and our development team. This individual will ensure our clients' needs are met, define project requirements, and oversee the design and development of software solutions. Acting as a business analyst, a project...
-
Sr Embedded Software Engineer
2 weeks ago
Jacksonville, FL, United States Medtronic Full timeWe anticipate the application window for this opening will close on - 26 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Job Title: Sr...
-
Sr Embedded Software Engineer
1 week ago
Jacksonville, FL, United States Medtronic Full timeWe anticipate the application window for this opening will close on - 26 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Job Title: Sr...
-
Sr Embedded Software Engineer
7 days ago
Jacksonville, FL, United States Medtronic Full timeWe anticipate the application window for this opening will close on - 26 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Job Title: Sr...
