Med Device QA Engineer | FAI/PPAP Specialist (Onsite NJ)

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

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.