Quality Technician; Inspection Support, FDA CFR Part 820 and ISO

Job Title

Quality Technician (Inspection Support, FDA 21 CFR Part 820 and ISO 13485)

Sparks, MD

9+ Months

Medical Device Company

M - F 8am - 5pm.

Quality

Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Under the direction of the Quality Engineering Department, provide technical support to incoming inspection and materials review. This would typically include: test and setup of received material for quality inspection; troubleshooting electrical and/or mechanical failures to determine root cause; writing and performing dispositions, repairs and reworks for rejected materials.

• Inspection Support – The technician will inspect All‑In‑One Computers for correct operation of touchscreen and computer hardware. Reimage and install software on the All‑In‑One computer.
• Material Review Support – Technician may be asked to support investigation of electrical/electronic or mechanical parts to determine root causes of failures and to assist with dispositions of failed parts.

Must have a high school diploma or GED. AA degree and/or trade school preferred. Preferred training in system or electronic troubleshooting.

• Understand engineering drawings and work instructions.
• Proficient in computer use and Microsoft Windows.
• Operates to the requirements of FDA 21 CFR Part 820 and ISO 13485.
• Proven experience troubleshooting systems.
• Fluent English verbal and written communication skills.
• Plans, schedules and executes assignments within guidelines of instructions received from project personnel.
• Provides engineering support to quality and manufacturing departments.
• Information sharing with other functional areas.
• Able to lift 50 pounds.