What are the responsibilities and job description for the Manufacturing Quality Engineer position at Technical Source?
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.
Salary : $65,000 - $85,000
