QvalFocus Inc. · 13 hours ago
Quality Engineer (Manufacturing & Remediation)
Minnesota, United States
Contract
Onsite
Senior Level
5+ years expQvalFocus Inc. is seeking an experienced Quality Engineer with a strong manufacturing and remediation background to support quality issue resolution within a regulated medical device environment. This hands-on role involves driving quality engineering and remediation activities, collaborating cross-functionally, and ensuring compliance with quality system and regulatory requirements.
Staffing & Recruiting
Hiring Manager
Shiva Kiran
Responsibilities
Lead and support quality engineering and remediation activities in a medical device manufacturing environment
Author and review technical documentation, including manufacturing changes and quality-related updates
Drive CAPA, NCRs, and remediation efforts from problem identification through closure
Analyze manufacturing and quality issues, perform root cause analysis, and implement corrective actions
Translate manufacturing and quality challenges into clear, actionable solutions
Collaborate cross-functionally with Manufacturing, Engineering, Quality, and Operations teams
Support execution and documentation within the Manufacturing Execution System (MES), including TAM Start
Ensure compliance with applicable quality system and regulatory requirements
Qualification
Required
5–10 years of experience as a Quality Engineer in the medical device industry
Strong background in quality remediation and manufacturing support
Hands-on experience with CAPA and NCRs
Proven ability to write technical and quality documentation, including manufacturing change documentation
Solid understanding of manufacturing processes and quality systems
Experience working cross-functionally to resolve complex issues
Familiarity with Manufacturing Execution Systems (MES); TAM Start experience preferred
Preferred
Quality Engineer who understands how manufacturing actually runs
Comfortable owning problems end-to-end—not just documenting them
Able to bridge Quality and Manufacturing effectively
Strong communicator who can influence across functions
Company
QvalFocus Inc.
QvalFocus: Focused on Delivering Quality that sets us Apart.
51-200 employees
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