Medical Device Quality Engineer – Validation Lead (Contract)

VTI Life Sciences; Pendleton (SC); On-site; USD 55,000 - 83,000; Part time

Job summary

VTI Life Sciences, Pendleton, SC, seeks a Medical Device Quality Engineer (Contract) to lead validation activities for laser marking/welding and other special processes. You will review IQ/OQ/PQ protocols, compile validation packages, and assist in SOP development.

Requires a Bachelor’s in Life Sciences/Engineering and 2+ years in GMP-regulated medical devices, with strong writing, organization, and cross-disciplinary communication skills. Project duration ~4 months.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related discipline.
• 2+ years of experience in 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 multi-disciplinary IT teams.
• Detail-oriented with 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 (Laser marking, Laser welding).
• Review equipment validation protocols (IQ, OQ, PQ) and reports for manufacturing medical devices such as metal instruments/ implants, ABS/Peek instruments/implants.
• Execute validation protocols for manufacturing equipment such as Laser marking, Laser welding, grinders.
• Compile executed validation packages.
• Support SOP development.
• Lead and write deviation investigations related to validations or assist in non-conformances/CAPA investigations.

Skills

Technical writing

Documentation

Project coordination

Multidisciplinary communication

Detail oriented

Education

Bachelor’s degree

Job description

VTI Life Sciences, Pendleton, SC, seeks a Medical Device Quality Engineer (Contract) to lead validation activities for laser marking/welding and other special processes. You will review IQ/OQ/PQ protocols, compile validation packages, and assist in SOP development.

Requires a Bachelor’s in Life Sciences/Engineering and 2+ years in GMP-regulated medical devices, with strong writing, organization, and cross-disciplinary communication skills. Project duration ~4 months.