Quality Engineer

Quality Engineer

The Quality Engineer is responsible for supporting and maintaining the organization's Quality Management System (QMS) and ensuring that products, processes, and documentation meet established quality standards, regulatory requirements, and internal procedures.

This position manages quality documentation throughout its lifecycle, supports quality assurance and continuous improvement initiatives, and partners with engineering, operations, and other functional teams to identify issues, reduce defects, and improve overall product and process quality.

The ideal candidate will have experience in quality systems, document control, auditing, root cause analysis, and quality assurance within a manufacturing, engineering, or similarly regulated environment.

Essential Duties & Responsibilities

• Maintain, organize, track, and control documentation associated with the Quality Management System.
• Manage the document lifecycle, including creation, review, approval, revision, distribution, retention, and archiving.
• Develop, implement, and maintain document control procedures and quality standards.
• Ensure controlled documents are accurate, current, properly approved, and readily accessible to appropriate personnel.
• Maintain document control databases, electronic systems, and quality records.
• Coordinate with engineering, operations, project management, and other departments to ensure required documentation is completed and submitted appropriately.
• Conduct periodic reviews and audits of quality documentation for accuracy, completeness, and compliance.
• Support internal and external audits by assembling documentation, records, and supporting information.
• Assist with maintaining compliance with applicable quality and regulatory standards, including ISO-based quality systems and other industry requirements.
• Develop and support quality assurance policies, procedures, processes, and continuous improvement initiatives.
• Monitor product and process quality and identify opportunities for corrective or preventive action.
• Investigate quality issues, nonconformances, and defects.
• Perform root cause analysis and assist with the development and implementation of corrective actions.
• Develop and execute appropriate inspection, testing, verification, or validation activities based on product and process requirements.
• Document, communicate, and track identified quality issues through resolution.
• Review product, process, and technical documentation for accuracy, completeness, and compliance.
• Partner with engineering, operations, production, and other stakeholders to proactively address quality concerns.
• Participate in continuous improvement activities designed to improve quality, efficiency, consistency, and reliability.
• Provide guidance or training to employees regarding quality procedures and document control requirements.
• May provide training, mentoring, or guidance to junior quality personnel.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Computer Science, or a related discipline preferred. Equivalent education and relevant professional experience may be considered.
• Approximately 2–4 years of experience in quality engineering, quality assurance, quality systems, manufacturing quality, or a related field preferred.
• Experience working within a manufacturing, engineering, production, or regulated environment is preferred.
• Knowledge of Quality Management Systems and document control practices.
• Familiarity with quality standards and regulatory requirements such as ISO 9001 or other applicable industry standards.
• Experience supporting internal or external quality audits preferred.
• Understanding of root cause analysis, corrective action, preventive action, and continuous improvement methodologies.
• Strong analytical, problem-solving, and critical-thinking abilities.
• Strong organizational skills with attention to detail and documentation accuracy.
• Ability to communicate effectively and collaborate across multiple departments.
• Ability to manage multiple priorities and work independently when necessary.

Computer & Technical Skills

• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Experience using Quality Management Systems (QMS), electronic document management systems, or similar platforms preferred.
• Ability to learn and work with software and systems used for quality documentation, reporting, tracking, and analysis.

Professional Competencies

Successful candidates should demonstrate:

• Accountability: Takes ownership of responsibilities, deadlines, decisions, and results.
• Continuous Improvement: Identifies opportunities to improve quality, processes, efficiency, and reliability.
• Integrity: Demonstrates professionalism, dependability, sound judgment, and ethical decision-making.
• Adaptability: Responds effectively to changing priorities, processes, and business requirements.
• Collaboration: Works effectively with engineering, operations, production, leadership, and other functional teams.
• Communication: Communicates quality expectations, findings, and recommendations clearly and professionally.
• Problem Solving: Uses data, analysis, and critical thinking to identify root causes and develop practical solutions.
• Attention to Detail: Maintains a high level of accuracy when reviewing products, processes, records, and documentation.

Physical Requirements

• Sit, stand, and walk for extended periods.
• Occasionally bend, crouch, stoop, twist, or reach.
• Use hands, fingers, and wrists to operate computers, equipment, and tools.
• Work in or around manufacturing or production equipment and machinery.
• Inspect products, components, labels, documentation, and materials for quality concerns or defects.
• Occasionally lift, move, push, or pull materials associated with the position.
• Wear required personal protective equipment (PPE), which may include safety glasses, hearing protection, protective footwear, or gloves.

Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

Work Environment

This position may operate in both office and manufacturing or production environments. Depending on the work area, employees may experience moderate noise, temperature variations, machinery, materials, and other conditions commonly associated with manufacturing or industrial operations.

The position requires the ability to work collaboratively with production, engineering, operations, and quality personnel while maintaining appropriate safety and quality standards.