Job Summary:

We are seeking a Manufacturing Line Quality Engineer to support quality assurance activities within a leading healthcare diagnostics manufacturing organization. This role focuses on maintaining product quality, resolving manufacturing quality issues, supporting process improvements, and ensuring compliance with FDA, ISO, cGMP, and Quality Management System (QMS) requirements. The ideal candidate will have a technical educational background, strong documentation skills, and an understanding of regulated manufacturing environments.

Key Responsibilities:

• Support manufacturing operations by identifying, investigating, and resolving production quality issues in accordance with established procedures.
• Provide quality assurance support on the manufacturing floor, ensuring compliance with approved processes and procedures.
• Review and maintain accurate Device History Records (DHR) and manufacturing quality documentation.
• Support manufacturing line clearances, product rework activities, and quality inspections as required.
• Assist with the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS).
• Ensure manufacturing activities align with applicable FDA, ISO, cGMP, and Quality System Regulation (QSR) requirements.
• Identify potential product defects and quality risks associated with manufacturing, testing, verification, and validation activities.
• Collaborate with production and quality teams to maintain product quality and support process improvements.
• Prepare and maintain technical documentation while communicating quality concerns effectively.
• Perform additional quality assurance responsibilities based on operational requirements.

Required Qualifications:

• Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Sciences, or a related technical discipline, or an equivalent combination of education and experience.
• Working knowledge of FDA regulations, current Good Manufacturing Practices (cGMP), Quality System Regulations (QSR), and ISO quality standards.
• Understanding of Quality Assurance, Quality Control, and manufacturing quality processes.
• Ability to review manufacturing documentation and identify potential quality or compliance concerns.
• Strong technical writing, documentation, and communication skills.
• Working knowledge of spreadsheets, word processing applications, databases, and inventory management software.
• Ability to work collaboratively with manufacturing, production, and quality assurance teams.

Preferred Qualifications:

• Exposure to medical devices, diagnostics, biotechnology, pharmaceuticals, or other regulated manufacturing environments.
• Familiarity with Device History Records (DHR), manufacturing inspections, line clearance, and rework processes.
• Understanding of manufacturing quality investigations, product defect identification, and process improvements.
• Familiarity with ISO 13485, FDA quality requirements, and Good Manufacturing Practices.
• Internship, academic project, or practical experience involving quality assurance, manufacturing operations, or regulated production environments.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $30/hr to $40/hr