Quality Engineer - Medical Device - Contract
About The Position
VTI Life Sciences is seeking a Medical Device Quality Engineer to support consulting projects 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, starts Monday, November 2, and is expected to last approximately four months. The work includes 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 a 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 processes, including laser marking and laser welding.
- Review IQ, OQ, and PQ equipment validation protocols and reports for equipment used to manufacture medical devices, including metal and ABS/PEEK instruments and implants.
- Execute validation protocols for manufacturing equipment, including laser marking, laser welding, and grinders.
- Compile executed validation packages.
- Support SOP development.
- Perform and 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.
Benefits
- Professional development and training
- Competitive compensation
- Excellent benefits
- 401(k) matching
- Stimulating and collaborative work environment
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What This Job Offers
Career Level
Mid Level
