Quality Engineer - Medical Device - Contract
VTI Life Sciences
Summary
Location: Pendleton, SC. Start date: Monday, November 2nd. Length of Project: Approximately 4 months. Employment Classification: Contract. Equipment: Grinders, Laser Welders.
Job description
Project Overview
Location: Pendleton, SC. Start date: Monday, November 2nd. Length of Project: Approximately 4 months. Employment Classification: Contract. Equipment: Grinders, Laser Welders.
Key Responsibilities
- Lead and coordinate validation execution activities with operations and engineering teams for special process related areas (Laser marking, Laser welding).
- Review equipment validation protocols (IQ, OQ, PQ) and reports for equipment used 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.
- Perform and assist in any validation activities but not limited to: SOP, Work instruction, forms, templates.
- Lead and write deviation investigations related to validations or assist in non-conformances/CAPA investigations.
Required Qualifications
- Minimum Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related discipline.
- Minimum 2+ years of experience in GMP-regulated Medical Device industry.
- Hands-on experience writing and executing validation protocols.
Key Competencies
- 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.
Requirements
- Minimum Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related discipline
- Minimum 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
Benefits
- Professional Development
- Training
- Competitive Compensation
- 401(k) Matching
Company overview
VTI Life Sciences is a leading ISO 9001:2015 certified Commissioning, Qualification, and Validation (CQV) services provider with over 27 years of experience in the life sciences sector. Founded in 1996 and headquartered in San Diego, California, the company specializes in providing comprehensive validation and compliance solutions to pharmaceutical, biotechnology, medical device, and FDA-regulated industries. VTI offers a full spectrum of services including computer system validation, cleaning validation, process validation, clean room certification, temperature mapping, process equipment qualification, and facility validation. The company operates with offices in San Diego, San Francisco, Boston, and China, serving global clients with their expertise in GMP/GLP facility compliance. VTI's core mission focuses on establishing long-term client relationships through consistently delivering high-quality validation services, supported by their dedicated team of professionals. The company has successfully executed hundreds of validation projects for leading healthcare companies worldwide, helping them bring life-enhancing products to market while ensuring regulatory compliance and operational excellence.