Quality Engineer

3 days ago

Franklin Square, New York, United States A-Line Staffing Solutions Full time

Quality Engineer

Location:
Hybrid – 4 days/week onsite (domestic travel required)

Rate:
$35–43/hr W-2 (No C2C)

Overview

We are seeking an experienced
Quality Engineer
to support new product development and sustaining engineering activities for medical devices. This role provides key quality engineering support from concept through commercialization and ongoing maintenance, ensuring compliance with design control processes and global regulatory standards.

Key Responsibilities

  • Apply quality engineering principles, tools, and methodologies to development and sustaining projects.
  • Serve as the Quality representative on cross-functional project teams for new product development and product improvements.
  • Ensure compliance with design control requirements and applicable FDA/ISO quality system regulations.
  • Review and approve new or modified design and process specifications, including product performance requirements and test methods.
  • Assist with supplier and internal quality system audits (Auditor-in-Training).
  • Drive measurable improvements to processes and procedures through structured problem-solving.
  • Support risk management, change control, process validation, and process capability initiatives.

Education & Experience

  • Bachelor's degree in engineering, science, or a related technical discipline.
  • Minimum 5 years of relevant Quality Engineering experience within the medical device, biotech, or regulated manufacturing industry.
  • Strong working knowledge of regulatory and quality system standards:
  • (e.g. 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR).

Skills & Technical Competencies

  • Proficiency in one or more Quality Engineering disciplines:
  • Acceptance sampling
  • Statistical process control (SPC)
  • Measurement system analysis/test method validation
  • Failure investigation/root cause analysis
  • Process validation
  • Risk management & FMEA
  • Supplier quality
  • CAPA and auditing
  • Experience independently executing development or maintenance projects in a regulated environment.
  • Strong written and oral communication abilities; able to generate reports, present findings, and influence cross-functional decision-making.

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