Job Title: Quality Engineer
Location: Phillipsburg, NJ
Type: Contract (Potential for hire)
Compensation: $40 - $45 hourly
Contractor Work Model: Onsite


JOB RESPONSIBILITIES
Regulatory Compliance

• Possess knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international MDR.
• Ensure compliance with QSR and GMP in all assigned areas
• Manage the CAPA process from investigation through effectiveness checks
• Maintain Design History Files, Technical Files, and documentation for audits

Technical Operations

• Understand Sterilization qualification and maintenance for medical devices
• Utilize Quality tools such as FMEA, Control Plan, and Process Flow
• Review Validation Protocols and Reports
• Apply background knowledge in Risk Management and technical writing

Project & Training Management

• Organize and prioritize tasks to meet project expectations and timelines
• Create and execute department and company-wide training programs

QUALIFICATIONS

• Education: Bachelor’s degree in engineering or a related field of study
• Experience: Equivalent work experience in an ISO-regulated or Medical Device background strongly preferred
• Technical Skills:
  • Proficiency in Verification and Validation (V&V)
  • Computer skills (Microsoft Office, Excel, Word)
• Communication: Strong verbal and written proficiency in English.

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