Know ATS Score
CV/Résumé Score
  • Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role: Sr. Software Quality Engineer (Computer Software Validation CSV).
United States Jobs Expertini

Urgent! Sr. Software Quality Engineer (Computer Software Validation-CSV) Job Opening In Jacksonville Florida – Now Hiring Macpower Digital Assets Edge Private Limited

Sr. Software Quality Engineer (Computer Software Validation CSV)



Job description

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:


  • 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.





Required Skill Profession

Other General



Your Complete Job Search Toolkit

✨ Smart • Intelligent • Private • Secure

Start Using Our Tools

Join thousands of professionals who've advanced their careers with our platform

Rate or Report This Job
If you feel this job is inaccurate or spam kindly report to us using below form.
Please Note: This is NOT a job application form.


    Unlock Your Sr Software Potential: Insight & Career Growth Guide


  • Real-time Sr Software Jobs Trends in Jacksonville, Florida, United States (Graphical Representation)

    Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Sr Software in Jacksonville, Florida, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 92929 jobs in United States and 521 jobs in Jacksonville, Florida. This comprehensive analysis highlights market share and opportunities for professionals in Sr Software roles. These dynamic trends provide a better understanding of the job market landscape in these regions.

  • Are You Looking for Sr. Software Quality Engineer (Computer Software Validation CSV) Job?

    Great news! is currently hiring and seeking a Sr. Software Quality Engineer (Computer Software Validation CSV) to join their team. Feel free to download the job details.

    Wait no longer! Are you also interested in exploring similar jobs? Search now: .

  • The Work Culture

    An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Macpower Digital Assets Edge Private Limited adheres to the cultural norms as outlined by Expertini.

    The fundamental ethical values are:
    • 1. Independence
    • 2. Loyalty
    • 3. Impartiality
    • 4. Integrity
    • 5. Accountability
    • 6. Respect for human rights
    • 7. Obeying United States laws and regulations
  • What Is the Average Salary Range for Sr. Software Quality Engineer (Computer Software Validation CSV) Positions?

    The average salary range for a varies, but the pay scale is rated "Standard" in Jacksonville Florida. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

  • What Are the Key Qualifications for Sr. Software Quality Engineer (Computer Software Validation CSV)?

    Key qualifications for Sr. Software Quality Engineer (Computer Software Validation CSV) typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.

  • How Can I Improve My Chances of Getting Hired for Sr. Software Quality Engineer (Computer Software Validation CSV)?

    To improve your chances of getting hired for Sr. Software Quality Engineer (Computer Software Validation CSV), consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

  • Interview Tips for Sr. Software Quality Engineer (Computer Software Validation CSV) Job Success
    Macpower Digital Assets Edge Private Limited interview tips for Sr. Software Quality Engineer (Computer Software Validation CSV)

    Here are some tips to help you prepare for and ace your job interview:

    Before the Interview:
    • Research: Learn about the Macpower Digital Assets Edge Private Limited's mission, values, products, and the specific job requirements and get further information about
    • Other Openings
    • Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.
    • Dress Professionally: Choose attire appropriate for the company culture.
    • Prepare Questions: Show your interest by having thoughtful questions for the interviewer.
    • Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.
    During the Interview:
    • Be Punctual: Arrive on time to demonstrate professionalism and respect.
    • Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.
    • Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.
    • Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.
    • Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.
    • Follow Up: Send a thank-you email to the interviewer within 24 hours.
    Additional Tips:
    • Be Yourself: Let your personality shine through while maintaining professionalism.
    • Be Honest: Don't exaggerate your skills or experience.
    • Be Positive: Focus on your strengths and accomplishments.
    • Body Language: Maintain good posture, avoid fidgeting, and make eye contact.
    • Turn Off Phone: Avoid distractions during the interview.
    Final Thought:

    To prepare for your Sr. Software Quality Engineer (Computer Software Validation CSV) interview at Macpower Digital Assets Edge Private Limited, research the company, understand the job requirements, and practice common interview questions.

    Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Macpower Digital Assets Edge Private Limited's products or services and be prepared to discuss how you can contribute to their success.

    By following these tips, you can increase your chances of making a positive impression and landing the job!

  • How to Set Up Job Alerts for Sr. Software Quality Engineer (Computer Software Validation CSV) Positions

    Setting up job alerts for Sr. Software Quality Engineer (Computer Software Validation CSV) is easy with United States Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!