QvalFocus Inc. · 12 hours ago
Supplier Quality Engineer
QvalFocus Inc. is a company operating in the biotech and pharmaceutical industry, and they are seeking a Supplier Quality Engineer. The role involves managing supplier qualification and quality management activities, conducting audits, and ensuring compliance with regulatory requirements.
Responsibilities
Manage supplier qualification and supplier quality management activities
Conduct and support supplier audits, supplier investigations, and CAPA management
Maintain supplier status and ensure compliance with GMP and regulatory requirements
Support change controls, complaints, procedures, and supplier-related training materials
Ensure compliance with FDA 21 CFR Part 211, ICH guidelines, and other applicable regulations
Support environmental monitoring and cleanliness zone compliance
Ensure data integrity and adherence to eCompliance standards
Collaborate cross-functionally to resolve quality and supplier-related issues
Qualification
Required
4+ years of experience in a GMP production environment
2+ years of experience in a GMP Quality Assurance environment
Experience in biotech or pharmaceutical industry
Strong knowledge of GMP and regulatory requirements
Experience with supplier audits, CAPA, investigations, and change control
Knowledge of IT applications and digital quality systems
Strong organizational, communication, and presentation skills
Ability to work cross-functionally in a fast-paced GMP environment
Company
QvalFocus Inc.
QvalFocus: Focused on Delivering Quality that sets us Apart.
H1B Sponsorship
QvalFocus Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase