Quality Engineer Job Listing at Kelly Services in Jacksonville, FL (Job ID 10119879)

Description

Software Quality Engineer:

Kelly Services is currently seeking a Software Quality Engineer  position for one of our top clients in Jacksonville, FL.

• Kelly Outsourcing Consulting Group KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Software Quality Engineer for a long-term engagement at one of our Global clients in Jacksonville, FL. This role is a full-time, fully benefited position.
• As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from.
• You'll also be eligible for paid time off, including holiday, vacation and sick/personal time.
• All KellyOCG employees receive annual performance reviews.

As a Software Quality Engineer  placed with KellyOCG you will be responsible for the following:
 
The Software Validation Engineer will be responsible for ensuring that computerized systems, manufacturing software, and automated inspection systems used in the production of contact lenses meet FDA, ISO 13485, and GxP standards. This role bridges the gap between IT, manufacturing, and quality, ensuring that software, including automated inspection systems, is validated, secure, and compliant throughout its lifecycle.

Key Responsibilities

• Computer System Validation (CSV): Work with team to execute CSV initiatives for automated manufacturing and laboratory equipment, ensuring compliance with 21 CFR Part 11 and GAMP 5 guidelines.
• Protocol Development: Author, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and modified software systems.
• Risk Assessment: Perform software risk assessments (e.g., FMEA) to identify potential validation failures and ensure product safety.
• Automated Inspection Systems: Lead the validation of complex visual inspection software and automated, high-speed camera systems used for detecting lens defects.
• Documentation & Compliance: Create and maintain comprehensive validation documentation, including User Requirement Specifications (URS), Functional Specifications (FS), and Traceability Matrices.
• Change Control: Evaluate, document, and approve changes to validated systems to maintain their validated state.
• Audit Support: Defend software validation documentation during internal audits, FDA inspections, and third-party audits.
• CAPA & Investigations: Investigate validation failures, conduct root cause analysis, and implement Corrective and Preventive Actions (CAPA). 

Qualifications:

• Education: Bachelor's degree in Engineering (Software, Biomedical, Electrical) or a related technical/scientific field.
• Experience: 3+ years of experience in Software Validation or Quality Assurance within a regulated industry (Medical Device, Pharmaceutical, or Biotech).
• Regulatory Knowledge: Strong working knowledge of FDA 21 CFR Part 11, Part 820 (GMP), and ISO 13485 standards.
• Technical Skills: Experience with computer system validation (CSV) tools and methodologies (e.g., HP ALM, Veeva, or similar Quality System Management Software).
• Documentation: Exceptional technical writing skills for developing protocols, reports, and SOPs
• Will work with customer validation engineering team on validation strategy
• Reviewing development life cycle documents and validation documents
  • Including but not limited to: URS, FRS, Design Validation, FMEA, Trace Matrix, Development Report / Characterization Report, IQ, OQ, PQ, Validation Report
• Support change control process as the SQE/QE role

Preferred Skills & Attributes

• Experience with automated visual inspection or machine vision systems.
• Experience with PLC or SCADA systems in manufacturing.
• ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE).

Important information: This position is recruited by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States.
 
Why Kelly®
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


As a Kelly Services employee, you will have access to numerous perks, including:

• Vacation and sick pay
• Paid holidays
• 401(k) plan
• Group medical, vision, dental, life, and short-term disability insurance options
• Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
• Kelly Learning Center offers free courses and trainings
• Weekly pay

 
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Find what's next with Kelly®.

As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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