Quality Engineer - Medical Device - Contract

VTI Life Sciences•Pendleton, SC

13h•Onsite

About The Position

VTI Life Sciences is seeking a Medical Device Quality Engineer to support consulting work in the pharmaceutical, biotechnology, and medical device industries. The successful candidate will lead and coordinate validation execution activities with operations and engineering teams for special processes, including laser marking and laser welding. The project is located in Pendleton, South Carolina, and is expected to last approximately four months, starting Monday, November 2nd. The role involves inspecting, reviewing protocols, providing support and feedback, developing SOPs, and executing validation activities. Equipment includes grinders and laser welders.

Requirements

Bachelor’s degree or higher in Life Sciences, Computer Science, Engineering, or a related discipline.
At least 2 years of experience in the GMP-regulated medical device industry.
Hands-on experience writing and executing validation protocols.
Strong technical writing and documentation skills.
Excellent organizational and project coordination abilities.
Ability to communicate effectively with multidisciplinary IT teams.
Detail-oriented with a strong compliance mindset.
Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

Lead and coordinate validation execution activities with operations and engineering teams for special-process areas, including laser marking and laser welding.
Review equipment validation protocols (IQ, OQ, PQ) and reports for equipment used to manufacture medical devices, including metal and ABS/PEEK instruments and implants.
Execute validation protocols for manufacturing equipment such as laser marking equipment, laser welders, and grinders.
Compile executed validation packages.
Support SOP development.
Perform or assist with validation activities, including SOPs, work instructions, forms, and templates.
Lead and write deviation investigations related to validations or assist with non-conformance and CAPA investigations.