Quality Engineer

Quality Engineer

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

Location: Jacksonville, Florida

Industry: Medical Device / Highly Regulated Manufacturing

Experience Required: 7–10+ years

Education: Engineering degree required

Position Summary: The Quality Engineer for Equipment Relocation oversees the compliance, qualification, and re-validation lifecycles for manufacturing equipment moving within or to a new medical device facility. This role ensures that equipment decommissioning, transit, reinstallation, and startup comply fully with FDA 21 CFR Part 820, cGMP, and ISO 13485 standards. You will partner with manufacturing, validation, and facilities engineering to author, review, and approve technical protocols, manage change controls, and guarantee that equipment returns to a fully compliant, production-ready state.

Key Responsibilities:

• Equipment Qualification & Validation
• Develop and execute comprehensive validation strategies and master plans for equipment relocation.
• Author, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and summary reports.
• Oversee Computerized System Validation (CSV) and software re-verification for relocated automated equipment.
• Coordinate Test Method Validation (TMV) and Gauge R&R studies to verify inspection and test equipment accuracy post-move.

Compliance & Change Control

• Manage Engineering Change Orders (ECOs) and formal change controls associated with facility layouts, utility hookups, and equipment repositioning.
• Assess relocation risks by conducting process and equipment Failure Mode and Effects Analysis (pFMEA / risk assessments).
• Review and update equipment history files, standard operating procedures (SOPs), and manufacturing instructions for technical accuracy and regulatory alignment.

Quality Operations & Risk Management

• Lead non-conformance investigations and resolve deviations identified during equipment startup or requalification testing.
• Initiate and drive Corrective and Preventive Actions (CAPAs) if equipment performance drifts from pre-move specifications.
• Conduct manufacturing readiness reviews to ensure the facility and equipment meet safety, environmental, and cleanroom qualification standards before full production release.
• Familiarity with Allen-Bradley, Siemens S7, and Schneider ELAU C600 platforms is highly desirable.

• Understanding of engineering change control, qualification documentation, document management, and regulated manufacturing practices.
• Familiarity with quality systems, safety requirements, and Good Documentation Practices.
• Strong written and verbal communication, organizational, and cross-functional coordination skills.
• Ability to manage multiple assigned tasks and meet established project deadlines.

Qualifications & Requirements Education & Experience

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related technical science.
• Minimum of 5 years of quality engineering experience within a regulated medical device or pharmaceutical manufacturing environment.
• Proven hands-on experience managing equipment moves, facility layouts, commissioning, and IQ/OQ/PQ execution.

Knowledge & Skills

• Deep working knowledge of FDA 21 CFR 820 (QSR), ISO 13485, and current Good Manufacturing Practices (cGMP).
• Strong technical writing skills for protocols, risk assessments, and change documentation.
• Familiarity with root cause analysis methodologies (5-Why, Fishbone) and statistical software (Minitab or JMP).
• Certification such as ASQ-CQE (Certified Quality Engineer) or Six Sigma Green/Black Belt is a strong plus.

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.