Quality Control Inspector (Medical Devices)

Location: Eagleville, Pennsylvania, United States; onsite in a production area/clean room

Company

Branch Medical Group, a subsidiary of hirify.global, manufactures implants for spinal and orthopedic applications and the instrumentation cases that house them.

What you will do

• Inspect raw materials, in-process components, subassemblies, assemblies, and final products against customer and internal standards.
• Execute, review, and approve Device History Records and ERP transactions to support timely product release.
• Control nonconforming materials by identifying, labeling, segregating, and managing component and assembly dispositions.
• Maintain, archive, proofread, and review quality records and documentation in accordance with GMP requirements.
• Use the QAD system to manage component and assembly dispositions and related queries.
• Collaborate with Production, Quality, Purchasing, engineers, and other functions to maintain compliance and support external audits.

Requirements

• Quality Inspector qualification or advanced studies in a relevant technical discipline.
• At least three years of directly related experience; medical device quality inspection experience is preferred.
• Knowledge of FDA Quality System Regulations and ISO 13485 is preferred.
• Ability to read job travelers, plans, sketches, diagrams, and procedural documents.
• Knowledge of fundamental geometry, fractions, percentages, relationships, and measurements.
• Strong organization, communication, attention to detail, critical thinking, and Microsoft Office skills.

Nice to have

• Experience with QAD, inspection of small components under magnification, measurement instruments, or sampling plans.
• IPC-A-610 certification or knowledge of resistance, spot, or laser welding of medical device components.
• Experience handling electrical components and working with ESD processes.
• Experience in a Class II or III medical device environment, complaints laboratory inspection, or receiving inspection.

Culture & Benefits

• Work is performed in a production area/clean room with some exposure to noisy equipment.
• The role requires independent work with limited supervision and effective collaboration with a culturally diverse employee population.
• Physical requirements include sitting, climbing or balancing, stooping, kneeling, crouching, crawling, and regularly lifting or moving up to 25 pounds.
• Occasional lifting or moving of up to 50 pounds and visual abilities including close, distance, color, peripheral, and depth perception are required.
• Employment follows company ethics, compliance, and socially responsible conduct standards.