Quality Engineer II

Intellectt INC; Columbia (OH); On-site; USD 70,000 - 110,000; Full time

Job summary

Intellectt INC is seeking a Quality Engineer II to support Quality Systems in a regulated medical device environment. The role involves change control, validation, investigations, and compliance activities across product and process transfers.

Ideal candidates have a engineering or science degree, experience in quality engineering within regulated industries, and strong knowledge of QMS, data integrity, and regulatory requirements.

Qualifications

• Bachelor's degree in Engineering, Science, or related field; Master's preferred.
• Experience in Quality Engineering within medical devices or regulated industries.
• Strong knowledge of Quality Systems, change management, validation, data integrity, and regulatory requirements.
• Experience with statistical analysis, sampling plans, SPC, and quality trending.
• Strong documentation, communication, organizational, and problem-solving skills.
• Experience with electronic QMS, ERP systems, and Microsoft Office.
• ASQ, RAPS, or related certification preferred.
• Ability to work independently with minimal supervision.

Responsibilities

• Support and maintain Quality Management Systems, including change control, validation, calibration, maintenance, and environmental monitoring.
• Lead and participate in cross-functional quality investigations and root cause analysis.
• Develop, review, and approve SOPs, validation protocols/reports, specifications, quality plans, and other QMS documentation.
• Support product/process transfers, design changes, and manufacturing improvements from a quality perspective.
• Manage change controls, quality impact assessments, and implementation activities.
• Perform statistical analysis, quality trending, SPC, and data-driven evaluations.
• Support CAPA, nonconformance, complaint, and quality event investigations.
• Support internal, customer, regulatory, and ISO audits.
• Ensure compliance with FDA QMSR/21 CFR Part 820, 21 CFR Part 11, ISO 13485, EU MDR, and applicable regulations.
• Support critical quality programs such as calibration, preventive maintenance, and environmental monitoring.
• Work independently and collaborate effectively with cross-functional teams.

Skills

Quality Engineering

Quality Systems

Change Management

Validation

Data Integrity

Regulatory Requirements

Statistical Analysis

Documentation

Communication

Problem Solving

Independent Work

Education

Bachelor's degree in Engineering or Science

ASQ/RAPS certification

Master's degree preferred

Tools

Electronic QMS

ERP Systems

Microsoft Office

Job description

Job Title: Quality Engineer II

Location: Columbia, OH

Duration: 06 Months

Job Description:

Quality Engineer II will support Quality Systems, process controls, validation, change management, investigations, and compliance activities within a regulated medical device manufacturing environment.

Key Responsibilities:

• Support and maintain Quality Management Systems, including change control, validation, calibration, maintenance, and environmental monitoring.
• Lead and participate in cross-functional quality investigations and root cause analysis.
• Develop, review, and approve SOPs, validation protocols/reports, specifications, quality plans, and other QMS documentation.
• Support product/process transfers, design changes, and manufacturing improvements from a quality perspective.
• Manage change controls, quality impact assessments, and implementation activities.
• Perform statistical analysis, quality trending, SPC, and data-driven evaluations.
• Support CAPA, nonconformance, complaint, and quality event investigations.
• Support internal, customer, regulatory, and ISO audits.
• Ensure compliance with FDA QMSR/21 CFR Part 820, 21 CFR Part 11, ISO 13485, EU MDR, and applicable regulations.
• Support critical quality programs such as calibration, preventive maintenance, and environmental monitoring.
• Work independently and collaborate effectively with cross-functional teams.

Qualifications:

• Bachelor's degree in Engineering, Science, or a related field; Master's preferred.
• Experience in Quality Engineering within medical devices or another regulated industry.
• Strong knowledge of Quality Systems, change management, validation, data integrity, and regulatory requirements.
• Experience with statistical analysis, sampling plans, SPC, and quality trending.
• Strong documentation, communication, organizational, and problem-solving skills.
• Experience with electronic QMS, ERP systems, and Microsoft Office.
• ASQ, RAPS, or related certification is preferred.
• Ability to work independently with minimal supervision.