Quality Assurance Specialist

Quality Assurance Specialist

We are looking for a Quality Assurance Specialist to support packaging, inspection, and order fulfillment activities for medical devices in Placentia, California. This contract opportunity with permanent potential is ideal for someone who brings a strong quality mindset, follows regulated procedures carefully, and works effectively in a team-focused manufacturing setting. The role contributes to the final preparation of cranial implants and related products by ensuring packaging accuracy, documentation completeness, and compliance with clean room and quality standards.

Responsibilities

• Carry out packaging and finishing tasks for medical devices by following approved bills of materials, work instructions, routing documents, and standard operating procedures.

• Support manufacturing line operations for cranial implants and related products while maintaining consistent attention to safety, quality, and teamwork.

• Prepare shipment-ready materials by assembling cartons, organizing packaging components, and securing products according to required configurations.

• Create and apply product, patient-specific, and packaging labels with close attention to identification details, coding accuracy, and specification requirements.

• Perform final inspection activities to confirm quantities, package setup, label correctness, overall packaging condition, and completion of supporting records.

• Complete production and quality documentation accurately to meet internal controls and applicable regulatory expectations.

• Retrieve finished inventory based on customer demand and scheduled orders to support timely and accurate fulfillment.

• Process outgoing orders by selecting the correct inserts, labels, and packaging materials for each request.

• Partner with quality and production teams to maintain compliance with company standards and regulated manufacturing practices.

• Follow clean room protocols and controlled-environment procedures to preserve product integrity during packaging and inspection work.

• At least 2 years of experience in quality assurance, manufacturing support, packaging, or inspection within a regulated environment.

• Working knowledge of quality assurance practices, documentation control, and work order execution.

• Ability to interpret bills of materials, routers, work instructions, and standard operating procedures accurately.

• Experience performing manual inspections with strong attention to detail, especially around labeling, counts, and packaging quality.

• Comfortable working in a clean room or other controlled production environment while following strict compliance requirements.

• Strong organizational and communication skills with the ability to collaborate effectively across production and quality teams.

• Familiarity with manual testing and quality verification processes; exposure to Selenium or automation tools is a plus but not required for core packaging responsibilities.