System One · 18 hours ago
Quality Engineer
Phillipsburg, NJ
Contract
Onsite
Mid Level
$40/hr - $45/hrSystem One is a leader in delivering outsourced services and workforce solutions across North America. They are seeking a Quality Engineer to ensure compliance with FDA regulations and manage the corrective and preventive action process within the medical device industry.
Human ResourcesStaffing Agency
Responsibilities
Possesses knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international medical device regulations (MDR)
Understands Sterilization qualification and maintenance as it relates to medical devices
Ensures compliance to QSR and GMP in assigned areas
Manage corrective and preventive action process from investigation through effectiveness checks
Maintain Design History and Technical Files, and documentation for internal and external audits
Organizes and prioritizes assigned tasks to ensure project meets expectations and timelines
Create and execute department and company training
Review Validation Protocols and Reports
Utilizes Quality tools such as FMEA, Control Plan, and Process Flow
Background in Risk Management a plus
Possesses competent technical writing skills
Qualification
Required
Possesses knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international medical device regulations (MDR)
Understands Sterilization qualification and maintenance as it relates to medical devices
Ensures compliance to QSR and GMP in assigned areas
Manage corrective and preventive action process from investigation through effectiveness checks
Maintain Design History and Technical Files, and documentation for internal and external audits
Organizes and prioritizes assigned tasks to ensure project meets expectations and timelines
Create and execute department and company training
Review Validation Protocols and Reports
Utilizes Quality tools such as FMEA, Control Plan, and Process Flow
Possesses competent technical writing skills
Education: Bachelor's Degree in Engineering or related field of study
Skills/Licensure: Computer skills (Microsoft, Excel, Word, etc.), Verification and Validation, proficiency in communicating (verbal and written) in English
Experience: Equivalent work experience in an ISO regulated/Medical Device related background
Physical Demands: Standing/Sitting, working at computer for normal periods
Preferred
Background in Risk Management a plus
Benefits
Health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans
Participation in a 401(k) plan
Company
System One
System One is a professional staffing firms.
Founded in 2008
5001-10000 employees
H1B Sponsorship
System One 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 (5)
2024 (6)
2023 (9)
2022 (10)
2021 (9)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
$301.8MKey Investors
TruistOaktree Capital ManagementProspect Capital Corporation
2021-01-28Debt Financing· $290M
2020-12-08Private Equity
2016-09-20Acquired
Leadership Team
Troy Gregory
Chief Executive Officer
Dan Moran
Chief Financial Officer
Recent News
2026-01-06
Company data provided by crunchbase