Quality Engineer

System One
Phillipsburg, NJ
Job Title: Quality Engineer
Location: Phillipsburg, NJ

Type: Contract
Compensation: $40 - $45 hourly
Contractor Work Model: Onsite

Quality Engineer
6 month assignment. Maybe longer

  1. Possesses knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international medical device regulations (MDR)
  2. Understands Sterilization qualification and maintenance as it relates to medical devices
  3. Ensures compliance to QSR and GMP in assigned areas
  4. Manage corrective and preventive action process from investigation through effectiveness checks
  5. Maintain Design History and Technical Files, and documentation for internal and external audits
  6. Organizes and prioritizes assigned tasks to ensure project meets expectations and timelines
  7. Create and execute department and company training
  8. Review Validation Protocols and Reports
  9. Utilizes Quality tools such as FMEA, Control Plan, and Process Flow
  10. Background in Risk Management a plus
  11. Possesses competent technical writing skills
Qualifications:
  • 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

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-1

Ref: #562-Joule Staffing - Edison

Posted 2026-02-24

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