Quality Assurance Engineer

System One, Inc.; Mahwah (NJ); On-site; USD 55,000 - 59,000; Part time

Job summary

System One, Inc. is seeking a Quality Assurance Engineer for a contract-based onsite role in Mahwah, New Jersey. The position offers hourly compensation and requires hands-on QA experience in medical device or related industries.

Responsibilities include FAI strategy, PPAP, change control, validations, and SOP/risk management documentation. Candidates should have a biomedical or mechanical engineering background and at least two years of industry experience.

Qualifications

• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering or related field.
• Minimum 2 years of industry experience.

Responsibilities

• Develop First Article Inspection (FAI) strategy, execute it and secure approvals.
• Support Production Part Approval Process (PPAP).
• Implement and review change control processes and assess change impact.
• Perform equipment and process validations.
• Update SOPs and risk management documentation as required.

Education

Bachelor’s Degree - Biomedical Engineering, Mechanical Engineering or related field

Job description

Job Title: Quality Assurance Engineer
Location: Mahwah, New Jersey
Type: Contract
Compensation: $40- 43/hr
Work Model: Onsite

Responsibilities

• First Article Inspection (FAI) strategy development, execution, and approvals.
• Production Part Approval Process (PPAP)
• Change control processes and change impact assessments
• Equipment and Process validations
• SOP and Risk Management documentation updates and reviews
• And more

Requirements

• Bachelor’s Degree - Biomedical Engineering, Mechanical Engineering or related field
• 2 + years of experience in industry required

  Preferred

  • Firm understanding of Med Device concepts highly desirable.
  • Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.

  System One, and its subsidiaries including 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.