Quality Engineer

Job Description

Job Description

Purpose Statement

The Quality Engineer II plays a critical role in driving product compliance and ensuring that customer requirements, industry standards, and regulatory expectations are consistently met. This position focuses on managing non-conformances and customer complaints through effective containment, root cause analysis, corrective action, and audits.

Key Responsibilities

Lead development and deployment of metrics within the Quality Management System (QMS) to ensure compliance and process health at the site level.

Ensure products meet customer specifications, regulatory requirements, and industry standards. Review and approve changes, deviations, and Engineering Change Orders (ECOs).

Create and maintain Master Validation Plans; support validation documentation and execution.

Act as a primary contact during customer and internal audits, and support certification and surveillance activities for the QMS.

Drive Corrective and Preventive Action (CAPA) activities, ensuring timely closure and communication.

Monitor manufacturing operations, identify quality concerns quickly, and lead containment actions when needed.

Oversee inspection strategies for receiving, pre-ship, and out-of-box audits. Maintain Certificates of Compliance and other required manufacturing quality records.

Promote quality awareness across operations by developing training programs, guiding operators, and embedding compliance into day-to-day activities.

Lead investigations into non-conformances and customer complaints, ensuring corrective actions are thorough and sustainable.

Education & Experience

Bachelor's degree in Engineering, Quality, or related field preferred.

Minimum 2 years of relevant professional experience (or equivalent combination of education and experience).

Consideration given to internal candidates based on demonstrated performance and contributions.

Additional Qualifications

Strong analytical, problem-solving, and decision-making skills using structured tools.

Experience in data analysis, root cause investigations, and experimental design.

Ability to design or improve systems and processes with a focus on repeatability, efficiency, and compliance.

Strong communication and collaboration skills; comfortable working in cross-functional teams.

Ability to mentor and coach technicians or team members in quality practices.

Demonstrated success leading projects involving multiple departments.

Physical Requirements

Work is performed in a manufacturing environment requiring PPE.

May involve standing, walking, sitting, computer use, and direct interaction with production equipment.

Tasks may include inspection, troubleshooting, or evaluating processes and fixtures.

Travel Requirements

Up to 40% travel may be required.

Why Apply Through Technical Source?

At Technical Source, we specialize in connecting top engineering talent with leading organizations. This role offers the opportunity to contribute directly to manufacturing quality excellence while growing your career in a supportive environment.

• ?? Apply today and take the next step in your career with Technical Source.