Overview
Quality Engineer Jobs in New York, United States at Invent Staffing
Title: Quality Engineer
Company: Invent Staffing
Location: New York, United States
Quality Engineer – Medical Device
Location: New York, United States
Duration: 12 Months Contract
Job Summary:
We are seeking a Quality Engineer with 3+ years of experience in the medical device industry to support manufacturing, process validation, and compliance with FDA, ISO 13485, and GMP standards. The ideal candidate will drive quality improvements, lead investigations, and ensure product and process integrity.
Key Responsibilities:
Support CAPA investigations, root cause analysis, and risk management (FMEA).
Assist in IQ/OQ/PQ validation activities for equipment and processes.
Review and update SOPs, work instructions, and quality documentation.
Conduct internal audits and support external regulatory inspections.
Collaborate with cross-functional teams to implement process improvements.
Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and MDR regulations.
Qualifications:
✅ Bachelor’s degree in Engineering, Quality, or a related field.
✅ 3+ years of quality engineering experience in medical devices or a regulated environment.
✅ Hands-on experience with CAPA, nonconformance investigations, and validation.
✅ Proficiency in statistical tools (Minitab, JMP) and risk analysis (FMEA).
✅ Knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP.
✅ Strong communication, analytical, and problem-solving skills.
Preferred:
Experience with Six Sigma, Lean Manufacturing, or ASQ certification.
Exposure to supplier quality management.
