Quality Engineer I

Job Description:

TrackX Technology is looking to hire a full-time entry level quality engineer. The engineer will assist in ensuring that TrackX products meet the standards of quality and regulatory compliance. You will work closely with cross-functional teams to support product development, testing, and continuous improvement efforts.

Responsibilities:

• Responding to day-to-day design, production, and customer quality issues related to the TrackX product.
• Perform root cause analysis and corrective/preventive actions (CAPA) investigations for non-conformance, product issues, process errors, and design problems.
• Collaborate with engineering, manufacturing, suppliers, and regulatory teams to resolve quality-related issues.
• Participate in product testing, inspections, and audits to verify product quality and compliance with specifications.
• Review manufacturing instructions for completeness, and correctness.
• Ensure procedures and work instructions are accurately and appropriately documented.
• Assist with the creation, review, and monitoring of established quality inspection procedures and test plans for new and existing products.
• Review and approve deviation requests from suppliers.
• Conduct statistical analysis of production processes and reporting of findings.
• Collect, organize, monitor, and distribute information related to supplier quality and process improvement.
• Assist in the evaluation of potential new suppliers and audits of existing suppliers.
• Assist in service and repair activities.
• Ensuring initial incoming product quality through First Article Inspection (FAI) and receiving inspection.
• Assist your direct report(s) in other duties as assigned.

Requirements:

• Located in or willing to relocate to the RTP area (Raleigh Durham Triangle).
• Bachelor's degree in engineering.
• 0-1 years of experience.
• Strong organizational, analytical, and problem-solving skills.
• Ability to adapt to changes in the work environment and manage tasks and competing project demands.
• Ability to plan and prioritize workload.
• Detail-oriented.
• Proficient with Microsoft Office.
• Strong verbal and written communication skills.
• Ability to effectively communicate technical concepts, problems, and ideas to various levels within the organization.
• Work collaboratively within and across cross-functional teams.
• Must be a US citizen or naturalized citizen.

Preferred Qualifications:

• Proficiency in reading and understanding various technical documents including engineering drawings, material specification sheets, etc.
• A basic understanding of quality assurance principles and regulatory requirements.
• Knowledge of FDA and ISO requirements related to medical devices and quality management systems.
• Knowledge or experience with 3D Printing (additive manufacturing) technologies and injection molding processes.